Senior Clinical Data Manager

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.

Your Responsibilities

  • 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

Your Profile

  • 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: mc@axepta.com

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Senior Clinical Data Manager

Jan 5, 2022Senior Clinical Data ManagerLausanne Full Time Permanent Job mc@axepta.com Life Sciences

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