Fusion Pharmaceuticals
  • Boston, MA, USA
  • Full Time

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Following Fusion's June 2020 IPO, the Company has cash to fund operations into 2023.

The Data Manager/ Sr. Data Manager will be responsible for managing and executing the design, testing, implementation and documentation of the clinical database build activities; collection and review of internal and external data; and the adherence to relevant processes throughout the lifecycle of clinical trials. The Data Manager is responsible for preserving data integrity and adhering to deadlines to achieve accurate and timely regulatory submissions and publications. This position will report to the Head of Clinical Operations. Key Responsibilities

  • Perform day to day Data Management activities for the assigned studies. If Data Management activities for a study are performed by a vendor, oversight of activities such as eCRF development, database set-up activities, data validation process, medical coding, SAE reconciliation, training of study site personnel in CRF completion, lab data transfer specifications, and data clarification processes.
  • Oversight of data review activities (cleaning activities, including internal cross functional listing review, external data reconciliation and data review). Support all activities leading to the study database lock.
  • Ensure consistency and data standards are followed across projects in data collection and processes.
  • Provide creative and effective ways to resolve data related or system related issues using professional concepts and considering company objectives.
  • Ensure Data Management activities are conducted according to applicable regulations and per the protocol.
  • Oversee or develop Data Management Plan.
  • Prepare the Data Transfer Agreements (DTA) or oversee the development of DTAs between the Data Management CRO and the External data vendors.
  • Serve as lead Data Manager on assigned clinical trials and attend clinical trial study team meetings.
  • Responsible for archival of data and study specific data management documentation.
  • Ability to monitor own activities and project status for successful project deliverables according to timelines.

Qualifications

  • Requires a bachelor's degree in a scientific discipline or equivalent.
  • 5-6 years as a Data Manager in a Pharmaceutical/Biotechnology company, or CRO.
  • Proficient in Electronic Data Capture (EDC) systems such as Medidata Rave.
  • Understanding of CDASH, SDTM, and medical coding dictionaries MedDRA, WHO Drug.
  • Good understanding of ICH, GCP and other applicable regulatory guidelines.
  • Effective verbal and written communication skills. Capable of working on multiple projects simultaneously.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Fusion Pharmaceuticals
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