Senior Manager, Clinical Data Management

Open for hire at one of the following locations –  Cambridge Erie Street. - Job ID: 7058 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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 Management 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.

• 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 conduction audit involving data management activities.

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 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 skills
• Excellent communicative skills
• Detail oriented
• Independent and pro-active way of working
• Team worker

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Cambridge Erie Street. Apply now for your preferred job and location through our careers site.

*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!