Our client is an innovating, dynamic and growing international pharmaceutical company, looking for a Senior Clinical Data Manager.
As part of the Global Biometrics team, under the responsibility of the Head of Data Management & Clinical Programming, our new Senior Clinical Data Manager you will be responsible for leading and overseeing all data management activities for in-house and outsourced clinical trials.
Operational leadership of data management tasks for assigned studies from start up to close out (including but not limited to eCRF design & edit checks, UAT, data management plan, data review & reporting, medical coding, data import/export, transformation to SDTM, database lock)
Ensure adequate documentation and application of internal and industry standards best practices across studies
CROs and Vendors oversight for all DM related activities providing consistent team direction/guidance and monitoring quality of work through key performance metrics
Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks
Participate in Data Management department infrastructure, by contributing to SOPs/Work Instructions development, CRF standards development and cross-functional process improvement initiatives.
Support PM & Contracts on budget related activities
Mentoring of junior staff
Minimum 7 years of clinical data management experience in the Pharmaceutical/Biotech industry
Extensive technical experience using EDC systems (ideally Medidata RAVE)
Strong experience in CRO and vendor oversight with consistent track record of on-time quality deliverables
In-depth knowledge of DM industry standards, best practices and CDISC implementation (CDASH, ODM, SDTM)
Bachelor’s degree or higher in the scientific, life sciences or computer sciences field or related discipline
Fluent English (oral and written)
For more information, please feel free to contact Morgane CAYUELA: firstname.lastname@example.org
Life Sciences Recruitment Specialist
Team Leader & Recruitment Management Life Sciences