Job Description

Title: Sr. Clinical Trial Manager

Location: Hybrid in San Francisco. 3-4 days per week onsite

Status: 6-12 month contract with possible conversion

Summary

Seeking a Senior Clinical Trial Manager (Sr. CTM) to oversee global clinical trials and support Phase II studies, with potential to expand to additional studies. This role involves managing internal and external stakeholders, including CROs, service providers, and trial sites, ensuring projects are delivered on time and within budget. The Sr. CTM will collaborate closely with teams in the US and international teams to ensure compliance with regulatory guidelines and company standards. A hybrid role based in South San Francisco.

Duties:

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables.
• Leads and/or participates in the development and review of study documents including CRF design, project plans, Service Provider Oversight plans, TMF (Trial Master File) plan.
• Must have high quality written and oral communication skills, with the ability to convey overall objectives and maintain open lines of communication between the internal stakeholders and service providers.
• Must have negotiation and project management skills with the ability to coordinate across projects/program/timelines.
• Ability to integrate into and collaborate effectively with a remote cross-functional team environment (US, APAC, EU) with a positive attitude.
• Ability to prioritize and handle multiple activities daily yet flexible and responsive to frequently shifting priorities.
• Models our core values: Passion, Integrity, Innovation, and Patient Focus

Education

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)

Experience

• 7+ years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities with increasing responsibility and scope
• Minimum of 3+ years study management experience in clinical and drug development, including management of studies outsourced to CROs.
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is desired.
• Experience working on global teams is desired, Asia-Pacific and EU highly preferred.

Job Tags

Similar Jobs