Senior Manager, Clinical Data Management
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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Senior Manager, Clinical Data Management
The Senior Manager Clinical Data 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.
Your main responsibilities are:
- Serves as primary point of contact for partners and sub-contractors 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.
What you have to offer.
- Natural/ life sciences or scientific background (university degree) or former experience in a CRO/ biotechnology
- Pharmaceutical company in a Clinical Data Management position; Minimum 5-7 years of experience in Clinical Data Management with 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
- Very good English (written and spoken)
- Experience in usual software (Word, Excel, Power Point, MS Project)
- Experience with at least once Clinical Data Management System (Medidata, OCRDC, Inform)
- Ready to take over responsibility
- Able to recognize problems and provide solutions
- Excellent organizational and communicative skills
- Detail oriented
- Independent and pro-active way of working
- Team worker
Benefits for you:
We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
How to apply:
Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.
Please note:
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected.
- Please note that BioNTech will run a background check during the hiring process
We are looking forward receiving your application.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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