Associate Director, Clinical Data Management

Role Summary

The Associate Director, Clinical Data Management provides core and comprehensive data management expertise to deliver high-quality data management outputs for clinical studies within their portfolio. They lead the Clinical Data Management Teams and oversee the execution of clinical trials from an operational and administrative perspective, including day-to-day people management, resource planning, and allocation of Data Management resources across portfolio/programs. They work with the (Senior) Director Clinical Data Management to develop forward strategies and processes. Location: Cambridge, US; Mainz, Germany.

Responsibilities

• Organizes and conducts team meetings.
• Takes care of team development, identification of high-performance team members and working on team development together with the (Senior) Director Clinical Data Management.
• Provides guidance to project teams on the oversight and supervision of CRO/third party vendors and organizes trainings as needed. Acts as a mentor for new incomers or may delegate to appropriate team member this activity. Provides continuous feedback to develop team members.
• Contributes to the development and review of portfolio documents (includes contracts, guidelines, budgets, metrics, KPIs).
• Complies with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
• Identifies the needs of new technology or tools for Data Management and takes active role during development and implementation.
• Supervises clinical data management activities within his/her portfolio/platform program and ensures it is per BioNTech standards and strategy.
• Escalates unresolved data or compliance issues to the functional manager(s).
• Provides guidance to Subject Matter Experts with regard to standard process developments.
• Ensures the trials processes are aligned within his/her portfolio/platform program(s) and escalates any deviations or foreseen non-compliance.
• Provides expert support to the Clinical Development Team, on study design issues for BioNTech development projects and portfolio/platform program(s).
• Represents his portfolio/platform program(s) team among other department leads and functions, and supports cross-functional interactions and problem solving.
• Participates in strategic vendor selection processes for Clinical Data Management, and actively participate in vendor relationship management, includes escalation.
• Provides input on developing, revising, and maintaining core operating procedures and templates.
• Provides support or assist Quality assurance department in conducting audits involving data management activities.

Qualifications

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

Skills

• Very good English (written and spoken).
• Effective communicative skills, active listener.
• Excellent organizational skills.
• Able to motivate and lead a team/ used to work in a team.
• Able to work under stressful conditions.
• Ready to take over responsibilities.
• Able to recognize problems and provide solutions.
• Detail oriented.
• Experience in usual software (Word, Excel, Power Point).
• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …).
• Independent and pro-active way of working.

Education

• University degree in natural/life sciences or related scientific field.