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Biometrics

Associate Director/Director, Data Management

  • Cambridge, MA
  • Added
Asset 1

Position Overview:

Beam is seeking a highly motivated, experienced senior manager, data management to lead clinical data management activities in support of Beam’s clinical trials. The ideal candidate will work closely with the Beam study team and CRO data management to ensure timely, accurate, complete, high quality data capture. This position will require hands-on work on clinical studies as the first in-house data manager.

Primary Responsibilities:

  • Work closely within biometrics function and clinical development to oversee all data management (DM) tasks and timelines.
  • Serve as primary DM contact and act as liaison with CROs and third-party data vendors.
  • Lead data management study start-up and maintenance activities including CRF design, cross functional CRF review, database building, edit check specifications, user acceptance testing, SAE reconciliation, review of CRF completion guidelines, CRO data management plans, external data transfer specifications and other essential documentations.
  • Provide expertise regarding CDASH and CDISC data standards and collaborate with Statistical Programming to oversee SDTM validation, review of validation report, SDTM Reviewer Guides and define.xml files.
  • Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, etc. that are generated for interim analyses, publications, CSRs, DSURs, IBs, and other business needs.
  • Support internal data reviews/QC of clinical data and coordinates and ensure successful electronic data transfers.
  • Oversight of database lock activities and ultimate archiving of study data.
  • Support GCP inspection readiness activities and serve as a primary point of contact for data management during inspections.

Qualifications:

  • Requires a Bachelor or master’s degree in a scientific or health-related field.
  • At least 10 years of experience in clinical data management within a pharmaceutical/ CRO, with experience in managing Phase I, II and III studies, from start-up through closure for multiple clinical studies.
  • Experience with EDC databases including Oracle Inform and/or Medidata Rave, CDASH/CDISC standards, GCP/ICH requirements, and corresponding FDA regulations.
  • Experience working with central and specialty labs/vendors.
  • Experience developing reports using J-Review and/or other CDM reporting tools.
  • Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable.
  • Must be well organized, detail oriented with strong analytical and problem-solving skills.
  • Must be able to dig in and check the cleanliness of the data including query resolution, data consistence and data cross checks etc.  
  • Experience and knowledge of gene/cell therapy and/or rare disease are desirable.
  • Must be self-motivated, and able to work independently and effectively with colleagues and vendors and demonstrate excellent verbal and written communication skills.
  • Ability to prioritize and manage timelines and shifting priorities within a fast-paced company environment.


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