Senior Manager, Clinical Data Management

Role Summary

The Senior Clinical Data Manager provides solid core and comprehensive data management expertise to provide quality data management deliverables on clinical studies. Responsible for the supervision of external sub-contractors that perform data management activities as deemed necessary for the conduct of the project. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Responsibilities

• Serves as primary point of contact for partners and subcontractors on data management deliverables and activities.
• Provides data management and technical expertise while working with CRO data managers and key decision makers for end-to-end DM activities.
• Supervises clinical data management activities. Performs direct negotiations with the CRO for timelines, process, quality issues.
• Organizes, conducts, and oversees clinical data management activities in accordance with BioNTech strategy and standards.
• Participates in the protocol development, creates and/or validates all the data management plan documents (CRF, Validation plan).
• Identifies the requirements for the development and amendments of the clinical database in cooperation with the trial team (Managers Clinical Trial, Medical/ Clinical Development experts).
• Validates or performs sponsor User Acceptance Testing of a clinical database.
• Provides support for sponsor clinical data medical review.
• Escalates unresolved data or compliance issues to the functional manager(s); works with CRO data managers, partners, vendors, internal team members for resolution.
• Ensures services and quality meet agreed specifications per the DMP and BioNTech quality standards.
• Ensures the final deliverables are provided to the Global Biometry Science team and provides support for data analysis/output generations.
• Participates in the development and implementation of new technology or tool.
• Participates and supports RFP process (for DM activities).
• Participates in the CRO selection for DM activities (review of proposals, bid defense).
• Provides support and reviews Scope of Work/Contracts and budgets for data management activities. Reviews invoices for data management activities as necessary.
• 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 8 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

Education

Additional Requirements