• Permanent Position
  • Suisse Romande
  • Recruiter: Usha Rao

Senior Clinical Data Manager – 4968 URA

 Our client is a multinational company based in French speaking part of Switzerland performing Clinical Research in areas such as nutritionals by prototyping capabilities to accelerate the translation of science into innovation. They offer dynamic, inclusive, and international working environment with many opportunities across different companies, functions, and regions. We are currently looking for a Senior Clinical Data Manager to work within their clinical development unit for a permanent position.

 As a Senior Clinical data manager, you will be responsible for developing and implementing the strategy for managing the trial data on all assigned clinical studies. You will manage all activities covering the data management process including study data base set-up, remote monitoring and data base lock.

 Beyond the traditional clinical data management aspect, the expectations are to fully embrace the power of digital towards decentralized or hybrid clinical trials and the implementation of risk-based data management strategy. You will need to have a pragmatic view on new emerging study designs, decentralized clinical trials, regulations and how technology innovations are dramatically reshaping the discipline of clinical data management.

 Main Responsibilities:

  • Provide clinical data management support to clinical projects
  • Review and update clinical study documents (e.g. protocols)
  • Set up the clinical database, including consistency checks defined in the Data Validation Plan
  •  Develop Data Transfer Agreement with external data vendors and/or core labs
  • Coordinate the clinical data quality review during the study execution
  • Collaborate with Biostatisticians on data validation and lock of the database, including management of discrepancies
  • Prepare and maintain key documents for the Data Management activities in a trial of Clinical Trials file.
  • Collaborate with cross-functional internal resources (clinical data manager, biostatistician, clinical project manager, scientists, medical directors) on different health benefit areas

 Qualifications and Experience:

  • MSc degree with a scientific background
  • At least 5 years’ experience in the field of clinical research
  • Up to date on regulations regarding clinical data collection and on clinical data standards such as: GCP (Good Clinical Practice), GCDMP (Good Clinical Data Management Practices), data privacy, and new regulations like GDPR (General Data Protection Regulation)
  • Experience and interest in digital transformation tools contributing towards data management
  • Experience with Data Management Systems such as Medidata
  • Project management skills
  • Central monitoring and analytical skills are a plus
  • Problem solving skills with a desire to improve current processes
  • Ability to ‘think outside of the box’
  • Excellent communication skills, both oral and written in English