Senior Clinical Data Manager*

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Everyone can achieve great things at BioNTech! We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. Our dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!

Key Responsibilities

The Senior Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. They would 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. The Clinical Data Manager will be responsible for managing data management components of project and study budgets and vendor performance.
 
Responsibilities
The areas of responsibilities will include
 
  • 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

Knowledge, Skills & Abilities

  • 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 infectious diseases and/or 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

What we offer

  • 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
  • And more!

To Apply, EEO and BioNTech Websites

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form.

*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!

BioNTech - As unique as you

https://biontech.de/biontech-us

www.biontech.de


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