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Manager, Clinical Data Management - Pune, India

i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research.

As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.

This position oversees data management operations and is responsible for the hiring, supervision and training of data management personnel. The Manager, Data Management must ensure that activities and processes performed are conducted according to i3 and sponsor requirements.

This position works closely with the data management and biostatistics teams, as well as clinical operational project teams. This position requires expertise in time and resource management, customer service and communications skills, personnel and project management, implementation of new technologies and data management processes.


You will be responsible for:

* Managing all personnel matters, conducting performance evaluations and hiring of Data Management department personnel.
* Communicating role, responsibilities, and quality and performance expectations to all team members.
* Direct the processes of database setup, data validation, database administration, database QC, and dictionary administration (e.g., medical coding).
* Train data management personnel in following GCP guidelines and standards, as well as establish good working practices.
* Ensures necessary training is provided and adequately documented.
* Managing projects and the resources necessary for their successful execution.
* Ensuring utilisation targets are being met on a regular basis.
* Assisting in the development of business development proposals related to Data Management.
* Assist in establishing and maintaining divisional policies and procedures (e.g. Standard Operating Procedures and Working Practices).
* Remaining informed of new developments in data management that are relevant to the industry.
* Maintaining effective employee relations by ensuring consistent personnel practices within the division.
* Working effectively with peers and sponsors, as needed.

And be able to demonstrate the following:

* BA / BS Degree in related field, or an equivalent combination of education and work experience
* Ability to work in and lead multi-disciplinary/cultural teams.
* Extensive experience leading data management activities for multiple and/or complex studies including supervising work of multiple team members. Previous management experience or demonstrated leadership ability.
* Proven ability to effectively recruit and develop staff.
* Proficient in the use of the clinical data management systems used at i3 Statprobe
* Ability to prioritize projects and work loads.
* Ability to work with other managers and project managers on a variety of projects at one time.
* Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH GCP.
* Excellent interpersonal and communication skills (written and verbal).

We Look Forward to Receiving your Application!