Senior Clinical Data Manager I

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials. As Senior Clinical Data Manager I (SrCDM1), you lead the data management activities of the Data Management department, managing, coordinating, reviewing and approving deliverables from database design and setup through cleaning and reporting to database locking. You also support RFPs and BD meetings, act as the primary contact for DM internally and externally, and help develop departmental processes, tools and training.

Key responsibilities

• Plan and project resources, manage tasks, timelines, risks and quality, and monitor budget, forecasts and scope changes
• Maintain project documents such as the data management plan, eCRF specifications, data validation plan and external data transfer agreements
• Lead database setup, including eCRF design and validation, and coordinate UAT
• Create training materials for EDC users and train staff
• Review and validate clinical data, and lead data cleaning strategy and data releases
• Perform or coordinate data transfers and reconciliations (SAE, PK, external lab data)
• Provide project metrics, status updates and advice on site performance, data trends and protocol compliance
• Organize quality review activities, prepare audit documentation and support audits
• Manage database maintenance, lock and close-out, and assist vendor contract negotiations
• Contribute as a subject matter expert to QMS processes, support client evaluations and proposals, and mentor staff

Required profile

• Life sciences, healthcare degree or equivalent combination of education and experience
• Minimum 5 years of relevant work experience as a Clinical Data Manager
• Minimum 5 years in drug development and/or clinical research
• Experience as a DM lead on several studies, preferably across therapeutic areas and phases, covering start-up, conduct and database lock

Required skills

• Thorough knowledge of ICH-GCP and 21 CFR Part 11, and awareness of GDPR/HIPAA and local requirements
• Experience with EDC, IRT and eCOA systems
• Relational database knowledge, validation plans and technical data management practices
• Hands-on experience with CDISC standards (CDASH, TAUG models)
• Experience developing data management standards

What we offer

• Comprehensive benefits package and competitive salary per location
• Departmental study and training budget
• Flexible working hours and leadership and mentoring opportunities
• Buddy program and internal growth opportunities