Senior Clinical Data Manager

Senior Clinical Data Manager

Debiopharm Group

Lausanne, Switzerland

Your Mission

As a Senior Clinical Data Manager, you will be accountable for the quality and timelines of data management activities across assigned clinical studies. You will play a pivotal role in ensuring that complete, accurate, and consistent clinical data is available to support our internal decision-making processes. Whether managing internal tasks or overseeing activities outsourced to external providers, you are the guardian of data integrity and quality.

Key Responsibilities

• Study Leadership: Lead and coordinate CDM activities, including eCRF design, EDC system setup, User Acceptance Testing (UAT), and database release.
• Operational Excellence: Perform data review, query generation, and data coding while ensuring timely data capture from both internal and external sources.
• Strategic Planning: Define and manage timelines for multiple studies or development programs.
• Documentation & Compliance: Prepare and review Data Management Plans (DMP) and validation plans in strict compliance with GCP, SOPs, and regulatory guidelines.
• Lifecycle Management: Oversee the lock, transfer, and archiving of clinical study databases.
• Collaboration: Act as a key member of the clinical study team, working closely with Clinical Trial Managers and other stakeholders in a matrix environment.

Requirements

Your profile

• Education: Scientific or technical background, ideally at a university level. In addition, any Project Management certification would be a plus.
• Experience: At least 10 years in clinical data management, working in matrix organization with at least one previous and solid experience in pharmaceutical industry and supporting Phase 1 to 3 studies. Project Management experience, an asset.
• Technical Expertise: Strong experience with various EDC systems and first experience or proficiency automating activities with AI.
• Leadership: Proven track record in leading data management studies and teams to deliver high-quality, regulatory-compliant databases.
• Skills: Excellent organizational, planning/coordination, proactivity and communication skills. Tech savvy, especially with Digital tools and AI
• Languages: Fluent in English; knowledge of French is a distinct asset.