Mylene Paumier at CK Clinical is recruiting for a Data Manager to join a global pharmaceutical company at their site based in Paris on a permanent basis.
As Data Manager the main purpose of your role will be to:
- Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines
- Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s)
- Ensure consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects
- Have business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes
- Respond to Health Authority requests for data management issues
- Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s)
- Provide input, review, and maintenance of global working practices and standards
- Contribute to the development of the Data Management organization through his/her leadership role within the DM Group
- Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
- Ensure appropriate company tracking systems are up to date and accurate
- Lead and support clinical & non-clinical special projects
- May deputize for Data Management Group Head and assist in coaching, training and mentoring of Data Management staff.
Qualifications and skills:
As Data Manager, you will have the following qualifications, skills and experience:
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
- Languages: Fluent English (oral and written) and French
- Ideally 5 or more years experience in drug development, with at least 4 years in Data Management activities
- Project team leadership experience required
- Good technical and problem solving skills
- Thorough understanding of clinical trial methodology, GCP and medical terminology
- Ability to work independently, under pressure, demonstrating initiative and flexibility
- Attention to detail and quality focused
- Good organizational, planning and project management skills
- Good interpersonal and communication skills and ability to operate effectively in an international environment
- Good negotiation skills
- Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
- Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.
How to apply:
For more information or to apply for this Data Manager position, please contact Mylene Paumier on 01438 743047 or email firstname.lastname@example.org. Please quote reference CL24263 in all correspondence.