Clinical Trial Leader
475 East Grand Avenue South San Francisco, CA 94080
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Serves as a member of one or more global cross-functional
- Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan: Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker / sample management plans, TMF, and CSRs.
- Liaises with cross-functional team members including the PET members to solicit input.
- Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF.
- Ensures TMF creation and QC completion.
- Supports EDC and CTMS systems and data maintenance.
- Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
- The capabilities required for this role are for a proven leader with the ability to manage delegated aspects of the study with minimal direction, is self-aware and takes initiative to fix and learn from mistakes, demonstrates good judgment in seeking guidance and exercises professionalism.
- Experienced in managing aspects of one or more early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.
- Highly effective verbal (including oral presentations) and written communication skills in English; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
- Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
- Demonstrated experience in at least one therapeutic area.
- Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).
- 5+ years of study management experience in clinical and drug development.
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
- Other (e.g. Travel): Willingness to travel domestically.
- Visual acuity and sufficient dexterity to constantly operate a computer and other office productivity machinery (i.e., a calculator, copy machine, and computer printer) in a stationary position.
- Work on nights or weekends is not typically required, however, interaction on global clinical studies requires flexibility for occasional teleconferences / meetings outside of core working hours.