Associate Director, Clinical Data Management

Role Summary

The Associate Director Clinical Data Management provides comprehensive data management expertise to deliver high-quality data management deliverables on clinical studies within their portfolio. Responsible for leading the Clinical Data Management Teams and overseeing the execution of clinical trials, including day-to-day people management, resource planning, and allocation of data management resources to portfolio/programs. Works with the Senior Director Clinical Data Management to develop forward strategies and processes.

Responsibilities

• Organizes and conducts team meetings.
• Develops the team, identifies high-performance members, and collaborates with the Senior Director Clinical Data Management on team development.
• Guides project teams on oversight and supervision of CRO/third-party vendors; organizes trainings as needed; mentors new staff and provides continuous feedback.
• Contributes to the development and review of portfolio documents (contracts, guidelines, budgets, metrics, KPIs).
• Ensures compliance with Good Clinical Practices (GCPs), regulatory guidelines, SOPs, policies, and CDM guidance documents where available.
• Identifies needs for new technology or tools for Data Management and leads development and implementation.
• Supervises clinical data management activities within the portfolio/program and ensures alignment with BioNTech standards and strategy.
• Escalates unresolved data or compliance issues to functional managers.
• Provides guidance to Subject Matter Experts regarding standard process developments.
• Ensures trial processes are aligned within the portfolio/program and escalates deviations or foreseen non-compliance.
• Provides expert support to the Clinical Development Team on study design issues for BioNTech projects and programs.
• Represents the portfolio/program team among department leads and supports cross-functional interactions and problem solving.
• Participates in strategic vendor selection for Clinical Data Management and vendor relationship management, including escalation.
• Contributes to developing, revising, and maintaining core operating procedures and templates.
• Supports or assists Quality Assurance in audits involving data management activities.

Qualifications

• Natural/ life sciences or scientific background (university degree) or relevant experience in a Clinical Data Management position within a CRO/biotechnology/pharmaceutical company.
• Minimum 12 years of experience in Clinical Data Management with oversight of DM activities as a Lead and DM project management.
• Profound knowledge of international guidelines (ICH-GCP) for the conduct of clinical research and experience with Clinical Database Systems and processes.
• Experience leading teams and resource planning.

Skills

• Very good English (written and spoken).
• Effective communication and active listening skills.
• Excellent organizational skills; ability to motivate and lead a team; comfortable working in a team and under stress.
• Responsible and proactive with strong problem-solving abilities.
• Detail-oriented; proficient with Word, Excel, PowerPoint.
• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, etc.).
• Independent and proactive work style.

Education

• University degree in natural or life sciences, or related field.