<rss version="2.0" xmlns:autn="http://schemas.autonomy.com/aci/" xmlns:ms="urn:schemas-microsoft-com:xslt" xmlns=""><channel><title>New Scientist Jobs</title><link>http://www.newscientistjobs.com/jobs</link><description>New Scientist Jobs</description><item><title>Clinical SAS Programmer Homebased</title><link>http://www.newscientistjobs.com/jobs/job/clinical-sas-programmer-homebased-surrey-200645894.htm</link><pubDate>Sat, 21 Nov 2009 08:00:52 +0000</pubDate><guid isPermaLink="false">199238</guid><description>Clinical SAS Programmer Homebased 
Fantastic opportunities are now available for experienced SAS programmers to work for a market leading Clinical Research Organisastion. This rapidly expanding CRO is on the lookout for Clinical SAS Programmers with a solid background of CDISC to join their established biostatistics department. Successful candidates will have the option of being based in a variety of European offices or working from home depending on your individual situation. 
As the SAS programmer you will be expected to provide SAS programming support on a variety of team projects, within all phases of the drugs development process. This will include supporting the production of statistical summaries for clinical trials, patient data listings, summary tables and figures using SAS tools. In addition you will be expected to ensure the quality of these statistical summaries, data listings and graphs, monitoring them for any inconsistencies and implementing the validation process. You will also ensure that all projects meet with the client's specific time lines and budgets. 
The ideal candidate will have a strong bachelor's degree in statistics or quantitative discipline with a minimum of 2 years SAS programming experience for a clinical research organisation or pharmaceutical company. You will be expected to have a good knowledge or ICP-GCP alongside excellent interpersonal and communication skills. 
Please note: This role is a homebased opportunity and previous experience in SAS programming within a CRO is essential.
In return you will receive a generous salary and competitive benefits packages, including flexible working hours and much more. 
For more information please call Kieron Mcdaid on 0121 616 3462 
Keywords: SAS, Programming, Clinical, Life Science, Biostatistics, Drug Development
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
</description></item><item><title>Senior Research Associate, Philadelphia, PA</title><link>http://www.newscientistjobs.com/jobs/job/senior-research-associate-philadelphia-pa-pa-pennsylvania-200631302.htm</link><pubDate>Fri, 20 Nov 2009 22:08:16 +0000</pubDate><guid isPermaLink="false">196398</guid><description>Senior Research Associate, Philadelphia, PA 
No relocation! For consideration, applicants must be located near the Philadelphia, PA area. 
Description:
Under the direction of the Director of the Immunology Laboratory, to promote and coordinate the multiple aspects of the growing research program of immunology Laboratory. The job involves performing diverse and complex clinical research activities including, but not limited to, writing study protocols and other research related documents, maintaining IRB and GCRC approval of study protocols, creating and instituting quality assurance procedures, performing research quality bone age and bone mineral density determinations, data management and quantitative analysis, collaborating in developing innovative research and educational programs, writing manuscripts and grant proposals, coordinating activities in multi-center studies, and serving as an educational resource for the laboratory and the Institution. This position has the potential for the candidate to develop into an independent investigator.
Qualifications:
MD or Ph.D. or equivalent in Immunology or related field with 2 years of experience in pediatric stress/psychometric biomarkers. Previous experience in cell culture, Elisa and PCR preferred. Ability to function independently in a clinical research setting. Excellent writing skills. Excellent communication skills to interact with staff, parents and children. Ability to handle confidential materials. Ability to handle multiple, time dependent tasks. Excellent organizational skills. Ability to use computers, learn new software applications. Ability to manage data and perform quantitative analysis. Ability to write progress reports and scientific manuscripts.
To apply please send your CV and three letters of recommendation to Wendy Rochlin by clicking Apply Now.
</description></item><item><title>Biostatistician - SAS Programmer Paramount Clinical Research</title><link>http://www.newscientistjobs.com/jobs/job/biostatistician-sas-programmer-paramount-clinical-research-berkshire-200645736.htm</link><pubDate>Fri, 20 Nov 2009 17:00:53 +0000</pubDate><guid isPermaLink="false">196121</guid><description>Biostatistician - SAS Programmer Paramount Clinical Research CRO
A multicultural global Clinical Research Organisation is seeking a Clinical Database and SAS Programmer to join their expanding team in Berkshire 
As the Biostatistician or SAS Programmer you will be providing SAS programming and technical support to a range of projects, in accordance to client's allocated timelines and budgets. You will regularly be expected to communicate with the clinical data manager in regards to programming related issues and assist them with data reviews. 
Your technical duties will include designing and building clinical databases and performing database validations. Inputting data into CRF's, programming and validating electronic data checks will also be required. If successful, you will help carry out ad hoc programming tasks and maintain coding dictionaries. This opening will require you to review and update SOPs, mentor other members of the team when required and interact with external suppliers for the delivery of electronic data. 
The ideal candidate will be educated to at least BSc level in Statistics or similar discipline. You will have over twelve months SAS/ Database programming experience with in a pharmaceutical or clinical research organisation. An ability to work as part of a team alongside excellent interpersonal skills is essential for this post.
In return you can expect to receive a generous salary and a competitive benefits package. This is a fantastic opportunity for career progression, within a continuously expanding biometrics team. 
For further details about this opportunity contact Kieron Mc Daid on +44(0)121 616 3462
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
</description></item><item><title>Research Data Services Officer</title><link>http://www.newscientistjobs.com/jobs/job/research-data-services-officer-london-200644709.htm</link><pubDate>Fri, 20 Nov 2009 10:14:34 +0000</pubDate><guid isPermaLink="false">194146</guid><description>Vauxhall, London
The General Practice Research Database (GPRD) is the largest validated Primary Care database in the UK. It is a crucial resource in the development of innovations in the field of drug safety assessment. Using GPRD and increasingly other European and global database resources, we are undertaking high quality research in drug safety, health outcomes and public health. Positioned within the MHRA, the independently run GPRD unit is internationally recognised as a high quality observational healthcare data research unit.
The major aim of your role will be to provide and administer data assurance and data management systems for the various data streams used by researchers for studies. These systems will be used to validate and verify research data sources and make them available to research scientists. You’ll also co-ordinate work between technical staff, epidemiologists and statisticians and ensure that processes, documentation and quality assurance/control meet the required standards.
Along with a degree in a relevant scientific discipline, you’ll have experience of managing data in a healthcare research environment. This will be matched with a sound understanding of developing and maintaining standard operational procedures and implementing process control and management solutions. Proven analytical thinking and knowledge of standards and guidelines associated with healthcare data research will also be important.
To apply please click the button below.
Closing date: 4th December 2009.
</description></item><item><title>Clinical Data Manager</title><link>http://www.newscientistjobs.com/jobs/job/clinical-data-manager-neuchatel-200642769.htm</link><pubDate>Wed, 18 Nov 2009 15:50:26 +0000</pubDate><guid isPermaLink="false">189869</guid><description>THE COMPANY
Philip Morris International (PMI) is the leading international tobacco company, with seven of the world's top 15 brands, including the world's number one brand. PMI has more than 75,000 employees and its products are sold in approximately 160 countries. The Company held an estimated 15.6% share of the international cigarette market outside of the United States in 2008. PMI is an Equal Opportunity Employer. For more information, please click the link within the 'View Contact Details' section below.
The primary focus of Philip Morris International’s Research &amp; Development is to research and develop new products which may have the potential to reduce the risks of tobacco related diseases. 
To strengthen the department of Applied Science – Clinical Assessment, in Neuchâtel, Switzerland, we are looking for a:
Clinical Data Manager
THE POSITION
The Clinical Data Manager (CDM) will be in charge of data management activities in the context of clinical studies conducted by PMI. The CDM will be the key contact for the Contract Research Organization (CRO) assuming the data management function for a clinical study, monitor the quality and timeliness of data management deliverables and ensure that requirements and timelines are met according to objectives. The CDM will further interact with Clinical Operations and the Study Biostatistician. In addition, the CDM will develop/improve internal processes and standards for data management and statistical programming in context of clinical studies. The CDM will report to the Manager Clinical Biometrics.
Main accountabilities:
• Coordinate data management activities from study set-up to database lock, including designing/reviewing the (e)CRF, reviewing the Data Management Plan and Data Validation Specifications, managing electronic data transfers between third parties, ensuring completeness and accuracy of data management related documentation, etc.
• Coordinate and monitor the CRO’s data management activities and ensure quality of CRO’s deliverables
• Coordinate the internal data review
• Ensure the compliance of the study database with PMI and CDISC standards
• Develop and improve internal processes and standards for data acquisition, data management and statistical programming
• Assist the Biostatistician in statistical programming for post-hoc analyses
THE CANDIDATE
Education:
• BS/MS in mathematics or a related fields
Work experience:
• Minimum of three years of experience as Clinical Data Manager in a clinical research environment
• Solid understanding of clinical trials methodology and terminology
• Solid knowledge of all data management tasks, CDISC standards, and medical coding
• Efficient programming techniques in SAS®
Additional skills and knowledge:
• Fluent written and oral English. German or French would be an advantage.
• Good communication skills as well as quality focus
• Ability to work independently in a multi-disciplinary team
We offer an excellent salary and benefits package as well as relocation allowance (where appropriate).
If you match our profile and you are interested in joining our dynamic team of professionals, please reply to our on-line recruitment site by clicking the Apply Now button below.
Closing date: 20th December
</description></item><item><title>Healthcare Applications Specialist (PAS / LIMS)</title><link>http://www.newscientistjobs.com/jobs/job/healthcare-applications-specialist-pas-lims-republic-of-ireland-200640841.htm</link><pubDate>Tue, 17 Nov 2009 14:41:20 +0000</pubDate><guid isPermaLink="false">194333</guid><description>Application Specialist (Healthcare Systems)
Life Science Recruitment has been given an exclusive mandate to source a number of Application Specialists in Healthcare Informatics for our client, a global healthcare software solutions provider with offices in over 20 countries and a range of award winning software solutions for the healthcare sector.
These positions will be based in the UK, however remote working from Ireland / Europe with travel to the UK for project meetings and implementation stages will be considered.
The Application Specialist will contribute to the successful development and timely deployment of robust products and customer solutions by providing application knowledge and product specialist services in the functional areas of product implementation, requirements scoping, design documents and change request testing. The Application Specialist will act as an "expert" product resource for customers, as well as communicating and prioritizing customer requirements to other areas of the business.
Responsibilities:
Liaise with customers in order to establish and define the work processes and requirements that are required to be addressed by the product application
Implement the product application in a manner that will suit the business requirements of the customer
Conduct training demonstrations and workshops as required
Implement and control change management requests from client
Deliver successful application implementation phases
SME for product application in regards to onsite implementations
Work with customers to identify potential changes within the parameters of the product where at all possible
Qualifications &amp; Skills:
A BSc, MSc or PhD degree in Science, Nursing, Technology or Health/Bio-informatics is desirable
Experience in clinical healthcare products or Laboratory Information Systems (LIS) / Lab Information Management Systems (LIMS)
Understanding of and experience with the implementation and management of the operational and managerial application of Hospital Information, Patient Administration, and Clinical Information Systems
Knowledge of Patient Administration Systems (PAS) 
Understanding of the importance of Health Informatics standards, reporting requirements and legislative controls
A solid grasp of computer systems, software development methodology and computer networking
An ability to handle multiple tasks simultaneously and within tight time constraints
Experience:
There are multiple grades of position on offer, ranging from entry-level (PhD Grad + 1 year exp.) to senior (10+ years Experience).
An excellent remuneration package including bonus and benefits is on offer to the right candidate.
For Immediate Consideration Please Apply Online Now
**************************************************************
If you would like further information before applying please contact:
Eamonn O'Raghallaigh MSc on +353 1 685 48 48
Your details will not be passed to a Third Party without your express Prior Consent.
*************************************************************** 
Life Science Recruitment | http://lifescience.ie 
Life Science Recruitment is Ireland's foremost specialist scientific and healthcare recruitment agency. We specialize in scientific, pharmaceutical, biotechnology, chemistry, quality management, clinical research, sales and marketing, medical, allied healthcare, regulatory affairs, engineering, pharmacy and research jobs in Ireland.
</description></item><item><title>Manager of Clinical Data Management - Swansea, Wales - CRO</title><link>http://www.newscientistjobs.com/jobs/job/manager-of-clinical-data-management-swansea-wales-cro-swansea-200638713.htm</link><pubDate>Thu, 12 Nov 2009 18:30:51 +0000</pubDate><guid isPermaLink="false">180764</guid><description>An outstanding opportunity to join one of the world’s leading contract research organizations and be part of a dynamic and growing international company. Join PRA as a Manager of Clinical Data Management based at our Swansea office, and help realise your career potential.
MANAGER OF CLINICAL DATA MANAGEMENT 
Location: Swansea, South Wales
PRA International is a global leader in providing clinical research services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, PRA International works with leading pharmaceutical and biotechnology companies, performing clinical research trials on many of the most advanced experimental drugs, biologicals and medical devices in development today. 
For more information please see our website: http://www.prainternational.com
Due to expansion, a new opportunity has arisen for a Manager of Data Management.
Working closely with the Director of Data Management, you will manage a team of Clinical Data Coordinators. Your responsibilities will include managing resources and resource projections to ensure project teams are consistent with client needs, recommend and implement clinical data management performance and productivity improvements, and participating in business development initiatives, including presentations and proposal development.
The successful candidate will have data management experience gained within a clinical research environment. In addition, you will have experience in a management capacity. You will have a life sciences degree and must have the ability to support and develop people.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale. 
To apply for the position please visit https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=185&amp;siteid=5199&amp;AReq=7288BR&amp;Codes=WLI to upload your CV. Please quote source reference code WNS on your covering letter.
If you have any questions please email grantclaire@praintl.com. For more information please visit our website http://www.prainternational.com/careers or call Claire Grant on 0118 918 1159.
PRA is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
KEY WORDS: MANAGER OF CLINICAL DATA MANAGEMENT / DATA MANAGER / DATA COORDINATOR
</description></item><item><title>Quality Director - Global Customer Lead</title><link>http://www.newscientistjobs.com/jobs/job/quality-director-global-customer-lead-horsham-200635998.htm</link><pubDate>Wed, 11 Nov 2009 15:34:55 +0000</pubDate><guid isPermaLink="false">177673</guid><description>Summary
This newly created global director level role focuses on a single client’s quality and regulatorary compliances and standards. With global responsibilities the role involves two-way communication at all levels to interact services provided to a major sponsor ensuring the seamless integration of worldwide clinical supply operations. 
The Company
Our client is the leading supplier of Clinical Trial Supply Services to their clients who are the major global pharmaceutical and biotechnology companies. Their services include the packaging and labelling, distribution / logistics, returns, IVRS software management that are used to service globally based clinical trials.
The Role
The Quality Director - Global Customer Lead will serve as a fully committed executive sponsor for all quality-related concerns and act as a senior liaison between a single, global pharmaceutical client and our own client’s service personnel. The role will encompass all of our client’s locations and will interact with personnel in multiple client locations.
The position holds responsibility for management of the single client’s quality and regulatory matters, cGMP compliance and two-way communications. Responsibilities also cover assurance that client requirements are developed, documented and agreed upon for manufacturing, packaging, testing and distribution/return of clinical supplies. The role also involves recommending and implementing “best practices” based on evaluation of client’s needs in conjunction with assessments of current operations. 
As a key client interface the position requires the promotion of innovation through technological advancement and continuous improvement plus a spirit of involvement to seek new challenges and opportunities through continual client interaction. 
Experience
The role requires an appropriate depth and length of Quality Assurance expertise gained at a senior and strategic level within the pharmaceutical or similarly regulated environment. It calls for strong leadership skills and an outstanding customer service focused approach. In summary you must demonstrate the ability to set the highest level of personal integrity to maintain and further advance the exceptional reputation of our client. 
Keywords: QA Manager, Quality Assurance Manager, QC Manager, QA Director, QC Director, Quality Control Director, Quality Assurance Director, cGMP, GMP, GCP, GLP, GxP, GDP, Process Validation, IMP, Clinical Trials, CTS, Clinical Trial Supply, Pharmaceutical Logistics, Cold Chain Logistics, Supply Chain Management, Compliance Director, Director of Quality 
SLS Services Ltd operates &amp; advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.
</description></item><item><title>Project Manager, Clinical Supply</title><link>http://www.newscientistjobs.com/jobs/job/project-manager-clinical-supply-bishops-stortford-200636287.htm</link><pubDate>Wed, 11 Nov 2009 11:51:14 +0000</pubDate><guid isPermaLink="false">177498</guid><description>Summary
A success story in the current climate; the company we represent continues to grow based on the increasing levels of outsourcing from their pharmaceutical company clients. This role is in the project management of supply chain solutions for clinical trial supply and clinical development.
The Company
Our client is the leading supplier of Clinical Trial Supply related services to pharmaceutical organisations who are running clinical trials. This involves setting up and managing complex global distribution networks. The company undertakes assignments on an individual project basis and is further expanding, 
The Role
Each clinical trial project is unique and this role will involve taking ownership of projects while acting as the client interface. Specifically you will manage and co-ordinate all technical and service aspects of a project with regard to clinical trial supply distribution. This will range from initial discussions with clients to defining logistical requirements, developing project specifications, project documentation and management of project related activities through to completion. Throughout the clinical trial you will coordinating all operational activities while ensuring the project plans are fully adhered to. 
Benefits
On offers is a competitive salary consummate with experience with on target annual bonus, 7½% non-contributory pension and private health cover. . 
Experience
We are seeking a talented individual with excellent communication skills who has good project management skills and expertise in the area of supply chains, distribution and/or logistics. Any specific expertise with pharmaceutical products or clinical trial or aspects such as temperature controlled cold chain/temperature controlled logistics would be advantageous. 
Keywords : Project Manager, Clinical Trials, Clinical Trials Supplies, Logistics, Distribution, Transportation, Pharmaceutical Logistics, CTS, Investigational Products, Supply Chain and Logistics, Supply Chain Logistics, Cold Chain Logistics, FMCG, Export, PM, 
SLS Services Ltd operates &amp; advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.
</description></item><item><title>Biostatistician SAS Programmer Paramount Clinical Research CRO</title><link>http://www.newscientistjobs.com/jobs/job/biostatistician-sas-programmer-paramount-clinical-research-cro-berkshire-200635797.htm</link><pubDate>Wed, 11 Nov 2009 08:58:15 +0000</pubDate><guid isPermaLink="false">177135</guid><description>Biostatistician - SAS Programmer Paramount Clinical Research CRO
A multicultural global Clinical Research Organisation is seeking a Clinical Database and SAS Programmer to join their expanding team in Berkshire 
As the Biostatistician or SAS Programmer you will be providing SAS programming and technical support to a range of projects, in accordance to client's allocated timelines and budgets. You will regularly be expected to communicate with the clinical data manager in regards to programming related issues and assist them with data reviews. 
Your technical duties will include designing and building clinical databases and performing database validations. Inputting data into CRF's, programming and validating electronic data checks will also be required. If successful, you will help carry out ad hoc programming tasks and maintain coding dictionaries. This opening will require you to review and update SOPs, mentor other members of the team when required and interact with external suppliers for the delivery of electronic data. 
The ideal candidate will be educated to at least BSc level in Statistics or similar discipline. You will have over twelve months SAS/ Database programming experience with in a pharmaceutical or clinical research organisation. An ability to work as part of a team alongside excellent interpersonal skills is essential for this post.
In return you can expect to receive a generous salary and a competitive benefits package. This is a fantastic opportunity for career progression, within a continuously expanding biometrics team. 
For further details about this opportunity contact Kieron Mc Daid on +44(0)121 616 3462
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
</description></item><item><title>Statistician for Early Development (m/f) / Ref. No. 101178/11</title><link>http://www.newscientistjobs.com/jobs/job/statistician-for-early-development-mf-ref-no-10117811-switzerland-200635396.htm</link><pubDate>Tue, 10 Nov 2009 15:16:20 +0000</pubDate><guid isPermaLink="false">176050</guid><description>Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts. 
We are looking for a 
Statistician for Early Development (m/f) 
for a permanent position in Basel region 
Reference number: 101178/11 
Your Duties: 
• Keeps abreast of statistical methodological developments through literature and attendance at courses and congresses. Obtains familiarity with applicable regulatory guidelines related to statistics and the disease areas working in.­
• Actively participates in the closer investigation of existing statistical methodologies and contributes to the development of appropriate new methodologies where needed. Participates in knowledge sharing and internal training activities within Biomathematics.­
• May lead a team of statisticians, experimental statisticians, pharmacometricians and programmers and coordinate all PDIM activities within one or more projects.­
• Makes presentations at professional forums.­
• Leads and is accountable for all statistical activities within the assigned drug development projects. Ensures that work is executed in a timely manner and to the required high statistical and reporting standards.­
• Represents Biomathematics in early clinical development teams and builds strong and sustainable relationships. Interacts with other departments, including regulatory affairs, data and project management, etc. In particular, interacts closely with scientists in Clinical Research and Exploratory Development and is able to convert scientific questions into statistical solutions.­
• Provides support for all statistical aspects of the early drug development project. Contributes to early clinical development plans covering all phases from entry into humans to launch. Aids in interpretation of all available data and contributes to an integrated assessment.­
• Plans and directs the programming of the protocol specific data displays. Assists in programming where appropriate.­
• Programs standard and special statistical analyses. Verifies the appropriateness of the planned analyses, assesses the impact of deviations from planned trial design, validates distributional assumptions and impact of outliers. Documents methods and procedures used in analyses.­
• Provides members of teams with results of analyses and interpretation.­
• Maintains up-to-date project documentation including that of presentation, analysis and graphics software.­
Your Qualifications: 
• University Education (MSc or PhD) in Statistics or another field (pharmacometrics, physics, mathematics, science).­
• Strong interest in the use of statistical methodologies in the pharmaceutical industry.­
• Experience in using statistical software (SAS or S-Plus/R).­
• Highly effective team worker with strong interpersonal skills.­
• Systematic and goal oriented working style.­
• Flexibility and confidence to handle ambiguities, changing demands.­
• Fluent in English.
</description></item><item><title>pCRF Supply Coordinator (m/f) / Ref. No. 103485/11</title><link>http://www.newscientistjobs.com/jobs/job/pcrf-supply-coordinator-mf-ref-no-10348511-switzerland-200635417.htm</link><pubDate>Tue, 10 Nov 2009 15:13:31 +0000</pubDate><guid isPermaLink="false">176051</guid><description>Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts. 
We are looking for a 
pCRF Supply Coordinator (m/f) 
contracting project assignment in Basel region 
Reference number: 103485/11 
Start of the project: asap 
Project duration: 6 MM 
Your Duties: 
• Supervise and coordinate all pCRF design support to produce paper Case Report Form (CRF) images used in Clinical Trials.­
• Plan, develop, implement and maintain Global and Therapeutic Area standard CRFs utilized by pCRF Design in clinical development. Ensure adherence to Global and Therapeutic Area standards by internal and external pCRF Designers.­
• Plan, develop, implement and maintain Patient Reported Outcome/Clinical Scales and initiate associated translation into local languages where required.­
• Ensure design, development and implementation of EDM standards for pCRF design and printing.­
• Ensure correct filing/archiving of all deliverables, whether completed by internal or external resources.­
• Estimate internal/external resources and budget required to support projects including development of implementation plan factoring staff availability, skills, systems, forms design requirements, and competing priorities.­
• Supervise and direct all pCRF Designers according to their level of experience, skills, and needs.­
• Give input to pCRF SOPs and guidelines. Actively review interdepartmental SOPs and guidelines which are relevant to EDM pCRF design.­
• Advises EDM management on information technology issues impacting pCRF performance, capacity and timeliness of clinical development projects as related to software, systems and personnel. Communicates awareness and recommends solutions where possible.­
Your Qualifications: 
• BSc/BA with experience in clinical data management or clinical study management in the pharmaceutical indurstry. ­
• Demonstrate supervisory experience on a global level. ­
• Demonstrate ability to assess, recruit and motivate personnel in a changing environment. ­
• Knowledge of medical procedures and terminology. ­
• Proficient knowledge of Clinical Research practices and procedures, stages of clinical trials, requirements and guidelines for CRFs in relation to protocol and data collection. ­
• Proficient knowledge of operating systems used within EDM, specifically Electronic Publishing system(s) for production of paper CRF images. ­
• Strong leadership, organizational, planning, analytical, and problem-solving skills. ­
• Excellent communication and interpersonal skills. ­
• Ability to effectively present the concept and impact of standardization, especially in reference to pCRFs and their associated policies. ­
• Be adaptive and aware of newly developing technologies, as well as being creative, imaginative and productive while working under time constraints and changing priorities.­
</description></item><item><title>Oracle Clinical Specialist- 2-level support (m/f) / Ref. No. 93188/1</title><link>http://www.newscientistjobs.com/jobs/job/oracle-clinical-specialist-2-level-support-mf-ref-no-931881-germany-200635347.htm</link><pubDate>Tue, 10 Nov 2009 14:34:07 +0000</pubDate><guid isPermaLink="false">175988</guid><description>Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts. 
We are looking for an 
Oracle Clinical Specialist- 2-level support (m/f) 
contracting project assignment Baden-Württemberg 
Reference number: 93188/1 
Start of the project: asap 
Project duration: 12 MM 
Your Duties: 
• The tasks to be executed are project work to implement new functionality ­
• Projects shall be conducted on own initiative by the consultant, in close co-operation with the internal staff­
• Projects will be defined with regards to goals and scope by the Technical System Lead (SL)­
• Delivery of project results will be evaluated by the SL­
• The consultant shall initiate all necessary communication on own initiative ­
• Examples projects include, but are not limited to: Implementation of a new standard load balancer, Design, Development and Implementation of new application portal and Design, Development and Implementation of system add-ons.­
• Second level support: ­
• Autonomous analysis of system problems reported by the company's users or identified by the company's IT staff, e.g. during system monitoring.­
• Initiate problem escalation at company's 3rd level support where appropriate­
• Work in close co-operation with the company's IT experts with regards to analysis of issues and malfunctions­
• Proposal of solutions on own initiative­
• Implement solutions and software patches as approved by the SL­
• Define and implement further monitoring mechanism as appropriate­
• Further support activities as defined and identified by the SL­­
• Used technologies­
• The following technologies are use within the context of this application: Oracle Database, Oracle Application Server, NetInstall, Active Directory Integration, PHP scripts for Web sites and load balancing logic, SSL/VPN gateway for external access and DMZ / Extranet. ­
­
• This list is just intended to show the complexity of the set-up. It is not expected that a potential candidate is the expert in all of this topics­
Your qualifications:
• Broad range of experience and technical skills in problem analysis­
• Experience with Oracle DB and Oracle Application server ­
• Experience with Unix and Windows operating systems­
• Further technologies (scripting languages, SQL,…) if needed ­
• Fluently English spoken and written­
• Excellent communications skills ­
• Willingness to conduct project work and second level support work­
• Preferable application knowledge of Oracle*Clinical / RDC / TMS­
</description></item><item><title>Phase I trial statistician (m/f) / Ref. No. 73034/1</title><link>http://www.newscientistjobs.com/jobs/job/phase-i-trial-statistician-mf-ref-no-730341-germany-200635344.htm</link><pubDate>Tue, 10 Nov 2009 14:33:57 +0000</pubDate><guid isPermaLink="false">175987</guid><description>Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts. 
For our customer we are seeking a 
Phase I trial statistician (m/f) 
contracting project assignment Baden-Württemberg 
Reference number: 73034/1 
Start of the project: asap 
Project duration: 12 MM 
Your Duties: 
For our client we are looking for a phase I trial statistician (m/f). The phase I trial statistician will work in our phase I/IIa biostatistics team (5 statisticians) and be responsible for planning and analysing clinical pharmacology studies. Typical study types are bioequivalence, bioavailability (Drug-Drug Interaction, Drug-Food Interaction, Drug Formulation BA studies), Single Rising Dose, Multiple Rising Dose etc. Furthermore he/she will collaborate with the clinical pharmacologist, clinical kineticist, daata manager and SAS programmer. For non-complex trials, the analysis and reporting may be contracted out to specialized CROs, while for complex trials, analysis and reporting is done inhouse involving SAS programmers to execute the Trial Statistical Analysis Plan (TSAP). A medical writer is also involved. Standard specifications (TSAP, tables, graphs &amp; listings) and analysis tools (SAS macros for BA/BE/dose proportionality) are available to handle routine tasks efficiently.
Your Qualifications: 
• You should have an MSc or PhD in statistics or math ­
• At least experience working as a statistician in on clinical pharmacology studies a pharmal company / CRO Excellent general biostatistics knowledge ­
• Good knowledge about pharmacology and kinetics­
­
</description></item><item><title>Phase I trial statistician (m/f) / Ref. No. 73034/1</title><link>http://www.newscientistjobs.com/jobs/job/phase-i-trial-statistician-mf-ref-no-730341-germany-200635338.htm</link><pubDate>Tue, 10 Nov 2009 14:33:48 +0000</pubDate><guid isPermaLink="false">175986</guid><description>Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts. 
For our customer we are seeking a 
Phase I trial statistician (m/f) 
contracting project assignment Baden-Württemberg 
Reference number: 73034/1 
Start of the project: asap 
Project duration: 12 MM 
Your Duties: 
For our client we are looking for a phase I trial statistician (m/f). The phase I trial statistician will work in our phase I/IIa biostatistics team (5 statisticians) and be responsible for planning and analysing clinical pharmacology studies. Typical study types are bioequivalence, bioavailability (Drug-Drug Interaction, Drug-Food Interaction, Drug Formulation BA studies), Single Rising Dose, Multiple Rising Dose etc. Furthermore he/she will collaborate with the clinical pharmacologist, clinical kineticist, daata manager and SAS programmer. For non-complex trials, the analysis and reporting may be contracted out to specialized CROs, while for complex trials, analysis and reporting is done inhouse involving SAS programmers to execute the Trial Statistical Analysis Plan (TSAP). A medical writer is also involved. Standard specifications (TSAP, tables, graphs &amp; listings) and analysis tools (SAS macros for BA/BE/dose proportionality) are available to handle routine tasks efficiently.
Your Qualifications: 
• You should have an MSc or PhD in statistics or math ­
• At least experience working as a statistician in on clinical pharmacology studies a pharmal company / CRO Excellent general biostatistics knowledge ­
• Good knowledge about pharmacology and kinetics­
­
</description></item><item><title>Phase III trial statistician (m/f) / Ref. No. 79396/1</title><link>http://www.newscientistjobs.com/jobs/job/phase-iii-trial-statistician-mf-ref-no-793961-germany-200635346.htm</link><pubDate>Tue, 10 Nov 2009 14:19:47 +0000</pubDate><guid isPermaLink="false">175971</guid><description>Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts. 
For our customer we are seeking a 
Phase III trial statistician (m/f) 
contracting project assignment in Baden-Württemberg 
Reference number: 79396/1 
Start of the project: asap 
Project duration: 12 MM 
Your Duties: 
The phase III trial statistician will work in the clinical biostatistics team (11 biostatisticians) and be responsible to support the preparation, conduct and reporting of phase III trials in the respiratory area. The candidate will work closely together with the two project statisticians. Additional interfaces are to the other members of the trial teams (Trial Manager, Data Manager and SAS Programmer) and the project teams (Project Data Manager, Project Statistical Programmer). The scope of work encompasses the definition and review of data quality checks and the review of statistical issues during study conduct. Thereafter, the preparation of specifications for analysis and reporting have to be created. A prototype Trial Statistical Analysis Plan for the entire phase III program of the compound has to be written and corresponding SAS programs and outputs have to be discussed and quality controlled. Statistical standards for the projects have to be reviewed. He/ she acts as a fully responsible trial statistician and will support the project statisticians. Depending on the scope of work the candidate may also work as a fully responsible trial statistician for phase II/III trials in the diabetes area. 
Your Qualifications: 
He/she should have a MSc or PhD in statistics or math. At least experience working on phase II/III studies in a pharmaceutical company/CRO and also excellent biostatistics knowledge in general.
</description></item><item><title>Clinical Data Manager (eClinical Consultant) (m/w) / Ref.-Nr. 111007/8</title><link>http://www.newscientistjobs.com/jobs/job/clinical-data-manager-eclinical-consultant-mw-ref-nr-1110078-germany-200635325.htm</link><pubDate>Tue, 10 Nov 2009 13:50:53 +0000</pubDate><guid isPermaLink="false">175959</guid><description>Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn sie Experten suchen. 
Für unseren Kunden suchen wir einen 
Clinical Data Manager (eClinical Consultant) (m/w) 
freiberuflich für ein Projekt in Hessen 
Referenznummer: 111007/8 
Projektstart: asap 
Projektdauer: 6 MM++ 
Ihre Aufgaben: 
• Unterstützung interner Projektteams im Bereich Electronic Data Capture­
• Aufbau und Pflege von Datenbanken, Query Management­
• Sicherstellung der geltenden Datenstandards­
Ihre Qualifikationen: 
• Tiefgreifende Erfahrung mit eClinical Trial Systemen­
• Erfahrungen im Bereich EDC­
• Sehr gute Kenntnisse des CDISC Standards­
</description></item><item><title>Excel Expert: Pharmaceutical Production Scheduler</title><link>http://www.newscientistjobs.com/jobs/job/excel-expert-pharmaceutical-production-scheduler-hove-200632930.htm</link><pubDate>Fri, 06 Nov 2009 12:08:50 +0000</pubDate><guid isPermaLink="false">170877</guid><description>• Title: Production Scheduler
• Excellent Microsoft Excel skills are essential
• ERP systems experience an advantage but not essential
• Location: Hove, East Sussex
• Salary: £18k - £19k + Benefits (depending on experience)
• Urgent requirement – immediate start preferred
The Company
An independent UK-based Contract Manufacturing Organisation (CMO), providing manufacturing, packaging and technical services to a variety of leading Pharmaceutical companies. Their main speciality is the production of tablets and capsules. With around 170 employees in Hove and Brighton, the company has a strong reputation for its efficiency and buzzing atmosphere, and has recently expanded due to funding from China.
The Role
You will be at the central hub of activity in a fast-paced company who pride themselves on producing top-quality goods with the most efficient turnaround possible.
You will be responsible for preparing production and packing schedules to make best use of available materials, liaising with key personnel to ensure that materials are available to use. Using your technical abilities to the full, you will prepare capacity utilisation reports for the management team, as well as taking charge of Batch Manufacturing / Packing Records (BMRs and BPRs) and issuing pick lists to the Warehouse.
Your hours will be 9am – 5pm, Monday – Friday.
Benefits
• 21 Days' holiday
• Pension
• Private Health Cover
Experience
The successful candidate must have advanced database skills (particularly Excel) and be able to maintain 100% accuracy even under fast-paced conditions. You must have first-rate communication and administration skills and be able to manage your own workload under pressure.
Previous experience of working in Pharmaceutical GMP manufacturing would be a considerable advantage, though knowledge of other GMP environments (e.g. Food or Cosmetics) would still be viewed favourably. Candidates will be considered with no Production experience as long as their Excel, admin and customer services skills are excellent. 
Keywords
Production scheduler, Excel, Microsoft Excel, spreadsheet, Excel spreadsheet, scheduler, production schedule, manufacturing schedule, pharmaceutical, GMP, manufacturing, packaging, packing, planning
SLS Services Ltd operates &amp; advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.
</description></item><item><title>E-commerce Specialist - Midlands</title><link>http://www.newscientistjobs.com/jobs/job/e-commerce-specialist-midlands-united-kingdom-200629345.htm</link><pubDate>Thu, 05 Nov 2009 14:52:04 +0000</pubDate><guid isPermaLink="false">168944</guid><description>Keywords:- Manager, e-commerce, scientific literature, database
Fantastic opportunity for a talented graduate with exceptional software/database skills. 
You will be responsible for enhancing and maintaining our clients substantial range of E-commerce material - sales, marketing and applications related brochures/flyers. 
A science degree is essential – ideally underpinned with hands-on lab experience – also mandatory is the ability to manage databases via MS Access.SQL programming experience, great attention to detail and exceptional communication skills would be highly beneficial.
</description></item><item><title>Clinical Systems Associate</title><link>http://www.newscientistjobs.com/jobs/job/clinical-systems-associate-switzerland-200631180.htm</link><pubDate>Thu, 05 Nov 2009 14:49:20 +0000</pubDate><guid isPermaLink="false">168936</guid><description>The purpose of this role, within the Clinical Operations team of a mid-size pharma, is to support and maintain clinical systems within Global Operations. As part of a small team and reporting into the Clinical Systems Manager, your focus is on system testing and specification reviews. You will be responsible for User Acceptance Testing of Global Operations Systems to include test documentation, testing and reporting the findings, organising and supervising testing and testing following patch releases and bug fixes. You will also be responsible for proposing system enhancements, supporting system maintenance and checking the quality of the data. You must be eligible to work in the EEA and be fluent in written and spoken English. 
You will have a good understand of the clinical trials process and of software development lifecycle. Excellent attention to detail and comfortable with preparing data in tables/report format.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
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