Senior Clinical Trial Management Lead

2 days ago

South San Francisco, California, United States Lifelancer Full time

About the Role

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We are seeking an experienced Senior Clinical Trial Manager to join our team.

About the Job

The successful candidate will be responsible for the execution of clinical trials from protocol concept through clinical study report. They will ensure completion of study deliverables, typically work on studies with moderate to high complexity, and proactively identify and resolve clinical project issues.

Main Responsibilities

  • Assess operational feasibility and lead start-up execution.
  • Manage comprehensive study timelines and metrics, and oversee adherence to them.
  • Participate in management/oversight of vendors; review vendor reports, budgets, and metrics; review and approve clinical vendor invoices against the approved budget.
  • Provide input and/or review study-related clinical plans and documents (e.g., Clinical Project Plan, Clinical Monitoring Plan, Patient Diary, CRF Completion Guidelines).
  • Prepare/review site-related documents (e.g., site-specific informed consent forms, study tools/worksheets, site contracts, site payments).
  • Assist in the selection of sites and countries; develop relationships with investigators and site staff.
  • Oversee/provide study-specific training and leadership to clinical research staff, including internal, contract, vendor, and site personnel.
  • Plan, execute, and/or lead study-specific meetings (e.g., study team meetings, investigator meetings).
  • Maintain study trackers (e.g., Study and Site Issue Log, Monitoring Visit Report Review Log, Protocol Deviation Log, CO Tracker for Shared Documents).
  • Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and applicable SOPs: participate in the planning of quality assurance activities and coordinate resolution of audit findings and CAPAs; ensure audit-ready condition of clinical trial documentation, including the TMF; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate; participate in site monitoring visits, as appropriate.
  • Interact with the study Medical Director and members of the cross-functional study team, as needed; interact frequently with cross-functional internal and external personnel (e.g., Regulatory Affairs, investigators, vendors).
  • May be responsible for managing/mentoring less-experienced Clinical Operations staff on the study team.
  • Perform other tasks, as assigned by the manager/designee to promote the efficient management/oversight of the clinical trial.

Requirements

To be considered for this role, you must have:

  • A Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field.
  • Minimum of 6 years of clinical trial experience in pharmaceutical, biotech, or CRO required, with a minimum of 3 years of trial management experience.
  • Strong understanding of GCP, ICH, and knowledge of regulatory requirements.

Preferred Qualifications

Oncology experience and global trial experience are desirable.

What We Offer

We offer a competitive compensation package, including a salary range of $155,000 - $170,000 per year, depending on experience.

Contact Information

Please apply on the Lifelancer platform: https://lifelancer.com/jobs/view/838ff9086368475b34a89e5da889a541

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