Associate Director, Clinical Data Management

Role Summary

Associate Director, Clinical Data Management. Provides data management expertise to deliver high quality data management deliverables on clinical studies within portfolio/platform programs. Leads Clinical Data Management Teams and oversees execution of clinical trials, including day-to-day people management, resource planning, hiring and allocation of Data Management resources. Works with Senior Director to develop forward strategies and processes.

Responsibilities

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

Qualifications

• Minimum qualifications: Natural/life sciences or scientific background (university degree) or prior experience in a Clinical Data Management position at 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) and experience with Clinical Database Systems and processes.
• Experience in leading teams and resource planning.

Skills

• Very good English (written and spoken).
• Effective communicative skills and active listener.
• Excellent organizational skills.
• Ability to motivate and lead a team; team-oriented.
• Ability to work under stressful conditions and take over responsibilities.
• Problem recognition and solution provision; detail oriented.
• Proficiency with Word, Excel, PowerPoint; experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, etc.).
• Independent and proactive work style.

Education

• Not specified beyond required/university degree in science or related field.