Manager / Associate Director, Clinical Data Management (Cell & Gene Therapy)

Open for hire at one of the following locations –  Cambridge Erie Street, Mainz Goldgrube. - Job ID: 4506 

 

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Manager / Associate Director, Clinical Data Management (Cell & Gene Therapy) 

 

Responsibilities

 

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.

 

• 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

 

Education

• Natural/ life sciences or scientific background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position

 

Experience

• Minimum 10 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 with Clinical Database Systems and processes

•Experience in leading teams and resource planning

 

Special Skills

•           Fluent English (written and spoken)

•           Effective communicative skills, active listener

•           Excellent organizational skills

•           Detail oriented

•           Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inf