Senior Manager, Clinical Data Management
BioNTech•Berkeley Heights, NJ
•$130,800 - $209,400•Onsite
About The Position
At BioNTech, we are more than a biotechnology company – we are a community of innovators dedicated to revolutionizing medicine. As a Senior Manager Clinical Data Management, you will play a pivotal role in ensuring the integrity and quality of clinical data that drives groundbreaking research and development. You will be at the forefront of managing data processes that contribute to advancing our diversified portfolio of product candidates. Join us in shaping the future of medicine within an environment that values collaboration, innovation, and diversity.
Requirements
- University degree in natural/life sciences or equivalent experience in Clinical Data Management within CRO/biotechnology/pharmaceutical settings with 7-10 years of experience in Clinical Data Management
- Profound knowledge of international guidelines (ICH-GCP) for clinical research projects
- Experience with Clinical Database Systems like Medidata or OCRDC along with proficiency in MS Office tools (Word, Excel, PowerPoint)
- Excellent organizational skills, attention to detail, and ability to work independently while being proactive
- Strong communication skills paired with a team-oriented mindset
Responsibilities
- Serve as the primary point of contact for partners and sub-contractors on data management deliverables and activities
- Provide technical expertise while collaborating with CRO data managers for end-to-end clinical data management activities
- Supervise clinical data management tasks, negotiating timelines, processes, and addressing quality issues directly with CROs
- Organize and oversee clinical data management activities aligned with BioNTech’s strategy and standards
- Participate in protocol development, creating and validating essential documents such as CRFs and validation plans
- Ensure compliance with Good Clinical Practices (GCPs) and regulatory guidelines while supporting medical review processes
Benefits
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
