Clinical Trial Mgr (GK)
San Francisco, CA - Pharmaceutical & Biotech - Hybrid - Contractor
Date Posted: 1/16/2024
Clinical Trial Manager – Contract
San Francisco, CA (Hybrid)
The Clinical Trial Manager is responsible for managing regional trials of high complexity or leading large multi-center global clinical trials across a range of study phases in various therapeutic areas, primarily cell and gene therapy. The role is also responsible for contributing to Clinical Trial Management department initiatives.
Assists Clinical Operations Program Lead or Global Study Lead in the development of operational strategy and schedules. Coordinates internal and external clinical trial activities of all assigned study team members involved in the planning, start up, running, and closure of assigned clinical trials. Creates detailed study timeline; monitors progress of timeline with cross-functional Study Team members. Drives operational strategy, overseeing development and execution of study plans. Manages approved trial budget(s) including ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to initiate vendor contract changes and review revised scope of work and budgets. Manages cross-functional vendor identification and set up and ensures appropriate ongoing oversight Investigator identification and selection. Contributes to the development of study documentation, including but not limited to clinical trial protocols, study plans and clinical study reports. Participates in cross functional study data review. Proactively identifies study risks and implements contingency plans. Represents Clinical Trial Management department as a technical resource in cross-functional initiatives or process improvement efforts (e.g. SOP and WI updates), often as leader. Acts as a resource for junior clinical trial management team members.
Knowledge and Skills:
Strong clinical trial management track record showing clear proficiency in project management skills, cross-functional study operations and vendor management. In-depth understanding of GCP, CFR and ICH Guidelines. Demonstrates detailed understanding of clinical protocol, intended study populations and drug development. Demonstrates ability to effectively interface with key medical personnel at investigational site(s). Excellent interpersonal and communication skills to explain difficult information and works to build alignment. Ability to effectively identify and resolve issues. Ability to problem solve within cross-functional teams. Excellent attention to detail. Ability to work successfully under pressure with tight timelines. Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint.
Education and Experience:
Bachelor's degree in life sciences discipline or relevant discipline. 7+ years' of relevant experience in the biopharmaceutical industry, or the equivalent combination of education and experience.
Please contact Greg Kane at email@example.com