Associate Director, Clinical Data Management

BioNTech SE • Cambridge, MA

77d

About The Position

The Associate Director Clinical Data Management provides solid core and comprehensive data management expertise to provide high quality data management deliverables on clinical studies within his/her portfolio/platform program(s). He/She is responsible for leading the Clinical Data Management Teams and overlooking the execution of clinical trials, with regard to operational and administrative aspects. This includes day-to-day people management, resource planning, hiring and allocation of Data Management resources to the respective clinical portfolio/platform program(s). The ADCDM is working closely with the (Senior) Director Clinical Data Management to develop forward strategies and processes.

Requirements

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

Nice To Haves

• 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.

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.

Benefits

• Competitive remuneration packages determined by the specific role, location of employment and the selected candidate's qualifications and experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees