Clinical Lead

il y a 4 jours


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

Clinical Data Management Expert Wanted

We are seeking an experienced Clinical Data Management professional to join our team at Ipsen Pharma.

About the Role

The successful candidate will be responsible for defining, implementing, and monitoring the Data Management strategy for clinical studies in our portfolio. This includes ensuring high-quality data collection, processing, and reporting, as well as overseeing external vendors and managing project timelines.

Key responsibilities include:

  • Developing a comprehensive data management strategy for each study, including data capture tools, management of external data, and data flow for submissions
  • Ensuring compliance with international standards (ICH, GCP, CDISC) and regulations related to clinical studies
  • Overseeing the activities of external vendors and reporting on project status to the Study Team/Submission Team
  • Maintaining high-quality databases within Ipsen's data warehouse and ensuring that requirements from the clinical study protocol and statistical analysis are fulfilled
  • Monitoring data quality, completeness, and trends between subgroups, and coordinating necessary activities to reach database lock milestones
  • Participating in the implementation of data quality systems and procedures, identifying areas for improvement, and contributing to the continuous improvement of Ipsen's Data Management system

Requirements

To succeed in this role, you will need:

  • More than 5 years of experience in Clinical Data Management, with proven project management capabilities in a pharmaceutical company or CRO
  • Excellent organizational and project management skills, with ability to manage multiple projects simultaneously
  • Advanced knowledge of clinical studies' Data Management, including electronic data capture and data management software (e.g., Medidata RAVE)
  • High-level expertise in international standards (ICH, GCP, CDISC) and regulations related to clinical studies
  • Good budget management understanding and ability to communicate efficiently with external vendors and internal partners
  • Familiarity with therapeutic area-specific standards and best practices on data collection and usage

What We Offer

In addition to a competitive salary ($115,000 - $140,000 per annum), we offer a range of benefits, including:

  • A dynamic and supportive work environment
  • Ongoing training and development opportunities
  • A comprehensive compensation package, including health insurance, retirement plan, and paid time off

Join Our Team

Ipsen Pharma is an equal opportunities employer and welcomes applications from candidates of all backgrounds. If you are a motivated and experienced Clinical Data Management professional looking for a new challenge, please apply today.



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