Senior Clinical Data Manager*
- Cambridge (Boston)
- Work experience
- Senior, very experienced
- Research, development, teaching
- Technical occupations (other)
Senior Clinical Data Manager*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech US is searching for a Senior Clinical Data Manager (SCDM) who will oversee the data management activities across a single clinical program or group of related studies. The data manager will also provide data management leadership and expertise to project and study teams and have a good knowledge of the end-to-end clinical research and data management processes. Finally, the SCDM will be responsible for managing data management components of project and study budgets and vendor performance.
Here, you’ll achieve greatness.
- Work closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end
- Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs
- Manage timelines and deliverables to complete data management activities, including those performed by CROs
- Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop CRF's to ensure the required information is captured for statistical analysis
- Coordinate with programming team and CRO regarding and database or programming changes needed throughout the study
- Track data management issues and ensure proper resolution and documentation
- Oversee the development of electronic Case Report Forms (eCRF), translate requirements to database specifications; oversee the development of eCRF completion Guidelines as needed
- Conduct User Acceptance Testing (UAT) of databases, including edit checks and reporting
- Collaborate on planning and requirements for study data cleaning. Coordinate and conduct data cleaning activities with other clinical line functions through a centralized team
- Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review
- Manage external data transfers protocols and standards
- Help identify and manage data entry errors, coordinate resolution via the CRO/CRA as appropriate
What you have to offer.
- B.S. in scientific or related field is preferred
- Minimum of 7 years as a Data Manager within Data Management or Clinical organization.
- Prior experience serving as a Clinical Data Manager leader for early phase oncology clinical trials, experience working as Data Management line function representative to Clinical Study Team
- Prior experience interacting with CROs, including direct oversight while coordinating day to day study data management activities
- Primary experience with CDMS process in the context of early phase clinical trials, working knowledge of SDTM/CDISC standards
- Experience with warehousing platforms preferred along with integration of complicated datasets in STDM/CDISC-compliant standards
- Basic understanding of relational databases, and field mapping
- CCDM certification preferred
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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