Clinical Operations Manager (Oncology) - Hertfordshire / Partly Field Based - Permanent
Do you hold 1 year + international Project Management experience? Are you looking for a company which is expanding and will offer long term career progression? This is an excellent chance to work for this global Pharmaceutical company in their large Oncology department. This a permanent role working on key Oncology studies Phase I-III. This role has a very international focus with trials worldwide, working with a dynamic team of Clinical Operations Managers and CRAs. You will be office based in Hertfordshire, although there is flexibility to work up to 2 days each week from home.
Role Summary
To co-ordinate all operational aspects of a clinical study within the Global Oncology development programme. You will lead the multi functional study team, co-ordinating activities and working closely with other team members from other functions such as data management, regulatory and pharmacovigilance. You will lead study teams at both a national and international level.
Role Description
* Work closely with the global study team members from different functional areas.
* Ensure that study is conducted in accordance with ICH/GCP guidelines, local regulatory requirements and company SOPs and in accordance with agreed timelines.
* Ensure quality of data are acceptable and suitable for regulatory submission
* Maybe involved in training internal staff and CRO staff for the study if required.
* Undertake co-monitoring visits with CROs when appropriate
Qualifications and Skills
A BSc or higher
1 years+ experience of independently leading a multi-national study either within Pharmaceutical Company or CRO in the UK or EU
A full understanding of current EU and ICH/GCP guidelines.
Used to handling vendors and have experience in reviewing study documents.
Prior experience of Oncology or working on a complex protocol is highly desirable
If this role is of interest please contact Holly Morgan on +44 (0) 118 959 4990 or e-mail holly@clinicalprofessionals.co.uk for more information.
Key Words: Oncology Project Management Operational Management Study Management London North London Hertfordshire Cambridgeshire Bedfordshire Buckinghamshire Middlesex Relocatable UK Anywhere Pharmaceutical Biotechnology Research and Development R&D Global PM
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