Clinical Documentation Specialist

Redwood City, CA, United States
Oct 11, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary: Clinical Document Specialist

  • Supports the Allakos Clinical Operations team by providing clinical project assistance and documentation support for all clinical studies. The position requires a highly-motivated, detail-oriented individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring excellence in a fast-paced, start-up biotech environment. Overall responsibilities will include support of Clinical Operations systems and processes from study start-up through study closure in support of trial objectives, regulatory submissions, inspections and corporate goals. This position reports to the Manager, Clinical Documentation. This position is remote based and will require travel to California for approximately 1 week every 6-8 weeks.

  • Primary Responsibilities
  • Trial Master File Administration
    • Set up study sites in Veeva Vault eTMF
    • Assign document collection tasks to eTMF users
    • Create study milestones
    • Complete User Acceptance Testing for system updates
  • Regulatory Documentation
    • Perform QC review of essential documents within the eTMF
    • Collaborate with research sites to collect required essential documents
    • Collect documents from central IRB online portals
    • Reconcile documents at end-of-study
  • Study Metrics
    • Generate and distribute pending document reports to trial team
    • Aggregate study-level metrics for weekly reports

  • Participate in on-site meetings with clinical team at Headquarters in Redwood City
  • Work with other clinical team members as needed on various tasks

  • Bachelor's degree preferably in Life Sciences or business; an equivalent combination of education and applicable job experience may be considered
  • Must possess:
    • Minimum of 1 year experience performing quailty control review of clinical regulatory documents.
  • Excellent verbal and written communication skills as well as interpersonal and organizational skills.
  • Proficiency in MS Office applications.
  • Self-sufficient and able to work with minimal oversight.
  • Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to earn and foster cooperation with and of others.
  • Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
  • Willingness and ability to travel as required.

The salary is competitive and commensurate with experience and qualiifications. Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.