A looking for a Clinical Trial Leader to join the Clinical Trials team with one of our major Biotech clients in South San Francisco, CA! If interested in the role, please apply with your most up-to-date resume.
Job Title: Clinical Trial Leader
Location: South San Francisco, CA
Role & Key Responsibilities:
- 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.
- 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.
- Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution to Protocol Execution Team Lead (PETL).
- Participates in selection of vendors (participates in the Request for Proposal (RFP) process), on a global scale, in collaboration with outputs from operational analytical tools to enhance and improve study execution.
- Oversees delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
- Contributes to global study site selection & management: Conducts global protocol, country, and site feasibility assessments.
- Partners with Site Contracts on development of site budget template and budget negotiations.
- Contributes to the development and active management of study-specific patient recruitment strategies through participation in enrollment planning workshops.
- Proactively identifies risks and develops risk mitigation strategies to ensure operational effectiveness.
- Collaborates effectively and participates in the CTL Forum and other departmental meetings.
- May be accountable for driving agenda and content for investigator meetings.
- 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.
- Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
- Ability to build trusting and collaborative relationships that promote innovation, knowledge-sharing and adaptation to change.
- Education / Qualification: Bachelors 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.
- Willingness to travel domestically.
*If you feel you have the skills to be a successful candidate in the role, please apply with your most up-to-date resume to this job posting.*
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Clinical Trial Manager