Clinical Data Management Project Lead

il y a 1 semaine


Les Ulis, Île-de-France Ipsen Pharma Temps plein

The Clinical Data Management Project Lead position at Ipsen Pharma offers a unique opportunity to join a dynamic team and take on a challenging role in the pharmaceutical industry. As a key member of our clinical data management team, you will be responsible for defining, implementing, and monitoring the data management strategy for one or more clinical studies in our portfolio.

About the Job

In this role, you will work closely with cross-functional teams to ensure that clinical data collected, processed, and reported are of high quality, rigorous, objective, and informative. You will also be responsible for ensuring that clinical databases in the project(s) are consistent with Ipsen data standards and presented to the analysis and reporting process in such a way that evaluation of data will withstand interrogation and examination by regulatory bodies.

Key Responsibilities
  • Define and implement a high-quality, timely, and robust data management strategy for the project
  • Oversee external vendor activities and deliverables, and report on the status of data management tasks as needed to the Study Team/Submission Team
  • Ensure compliance of data management deliverables with Ipsen rules and standards, including standard database within Ipsen data warehouse
  • Monitor data quality, completeness, and trend between subgroups at different pre-identified and agreed time points
Requirements

To be successful in this role, you will need to have:

  • At least 4 years of experience in clinical data management, with proven project management capabilities in a pharmaceutical company or CRO
  • Advanced knowledge of clinical studies' data management and international standards (ICH, GCP, CDISC...)
  • High level of expertise in the use of data-management software, including Medidata RAVE
  • Good level of expertise in oversight and management of external vendors
  • Excellent IT and Microsoft Office skills
About Ipsen Pharma

Ipsen Pharma is a leading global specialty-driven pharmaceutical company committed to improving patients' lives through innovative medicines and research programs. We offer a competitive salary package, including an estimated $120,000 - $150,000 per year, depending on location and experience.


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