Specialist* Clinical Data Management
- Work experience
- Research, development, teaching
Become a member of the BioNTech Family!
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.
Specialist* Clinical Data Management
Your main responsibilities are:
- May serve 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 the Manager clinical Data or CRO data managers and key decision makers for end-to-end DM activities.
- Supports supervision of clinical data management activities with assistance of a Manager clinical Data or an Associate Director Clinical Data Management. Performs direct negotiations with the CRO for timelines, process and 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. Performs ad hoc clinical data reviews and data quality checks.
- Supports the delivery of the final clinical data to the Global Biometry Science team.
- Participates in the development and implementation of new technology or tool.
- Participates in the CRO selection for DM activities (review of proposals, bid defense).
- Provides support and reviews budgets for data management activities. Reviews invoices for data management activities as necessary.
What you have to offer.
- Minimum 2-3 years of experience in Clinical Data Management with practice in oversight of DM activities 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.
- Natural / life sciences or scientific background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position.
- Experience with at least one Clinical Data Management System (Medidata, OCRDC,)
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 5197 (please indicate for inquiries) #DCA-LI
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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