Manager, Clinical Data Management

Cambridge, MA

JOB TITLE: Manager, Clinical Data Management
EFFECTIVE DATE: October 15, 2019
CLASSIFICATION: Full time Employee
FUNCTIONAL AREA: Clinical
WORK LOCATION: Cambridge, MA
SUPERVISOR: Director, Data Management
MANAGERIALLY RESPONSIBLE FOR: N/A

ESSENTIAL JOB FUNCTIONS:

  1. Collaborate with internal and external team members for the planning and execution of clinical trials as it relates to data management.
  2. Responsible for ensuring quality and data integrity of clinical databases.
  3. Work with clinical team to define study data review plan specifications.
  4. Lead clinical team in the review of clinical study data.
  5. Prepare and provide data listings and reports as required (e.g. leadership reporting, DMCs, etc.).
  6. Provide review and guidance to protocol development as it relates to data collection and management.
  7. Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.
  8. Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).
  9. In consultation with the Director of Data Management, provide guidance to Vendor Management as it relates to development of contracts with external vendors for data collection, cleaning, and reporting; review of Scopes of Work related to data management responsibilities.
  10. Partner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.
  11. Responsible for tracking and documentation of data management decisions.
  12. Responsible for initiating and chairing meetings associated with various clinical programs; document and distribute meeting minutes for chaired meetings.
  13. Provide support and contribute to the development of clinical trial timelines as it relates to data management activities.
  14. Assist with the review and approval of study vendor payments as it relates to data management.
  15. Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

  1. A./B.S. degree in Biology, Computer Science or related scientific field.
  2. 5+ years’ experience in data management or relevant work in the pharmaceutical/biopharma industry. Experience in oncology
  3. Sponsor side experience in managing and overseeing CRO delegated DM activities preferred.
  4. Experience in managing external vendors (Labs, Imaging, ECG).
  5. Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations.
  6. Experience with CDISC standards.
  7. SAS programming experience a plus.
  8. Experience working in 1 or more EDC systems (Rave, InForm, Medrio, etc.) and software applications such as Word, Excel and
  9. Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.
  10. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  11. Excellent interpersonal skills in addition to verbal and written communication skills.
  12. Flexibility to travel up to approximately 5% of time.

 

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity.  Employee may occasionally be required to travel.  The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to careers@kuraoncology.com