Senior Manager, Clinical Data Management

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11678 About the role: 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. Your contribution: 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 A good match: 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 At BioNTech, your work has the potential to impact lives globally. Your benefits and remuneration: Expected Pay Range: $130,800/year to $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: 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 …and more! More details to be shared. Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter. #J-18808-Ljbffr