Clinical Trial Manager

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer. Reporting to the Head of Clinical Operations, the Clinical Trial Manager (CTM) will be accountable for the day-to-day operational oversight of at least one clinical trial in all Regulatory phases, including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This individual will have cross-functional leadership responsibilities.

RESPONSIBILITIES:

• Maintain and manage multiple tracking systems related to study details, training, and trial metrics (for example: enrollment, data cleaning/queries management, biosample tracking, IMV tracking, etc.)
• Contribute or QC study documents/materials (ICFs, CRFs, CCGs, TMF Plan, and other essential clinical study documents)
• Assist with PSVs, SIVs, IMVs, and COVs including creating materials and tools needed to conduct these visits
• Review monitoring visit reports, as needed
• Support clinical finance and study lead with the review, tracking, and management of study and site-specific budgets
• Oversee the trial master file (TMF), including set-up, maintenance, ongoing quality review, and final reconciliation
• Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)
• Interact with investigational sites, vendors, and internal stakeholders
• Attend and contribute to Study Execution Team (SET) meetings, produce and distribute meeting agenda and minutes, as needed
• Assist with site communications for updates, clarification, or distribution of key study information
• Organizes and prioritizes numerous tasks and completes them under time constraints
• Partner with Study Lead to perform or oversee various tasks required to successfully execute one or more clinical trials

QUALIFICATIONS:

• BA/BS degree (Health or Life Sciences preferred)
• Minimum 2 years experience in clinical trials as a Clinical Trial Manager at a biopharmaceutical company.
• Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for clinical research required (e.g., FDA, EMA, ICH-GCP), and data management Working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH (R2) guidelines and hands-on regulatory, clinical operations, or clinical trial monitoring experience.
• Excellent organizational, problem-solving, and decision-making skills
• Strong interpersonal skills, strong team player
• Proficiency in clinical trial management software and systems (e.g., EDC, TMF)
• Willingness to travel as needed

PREFERRED QUALIFICATIONS:

• Advanced degree in a relevant scientific field (e.g., life sciences, pharmacy)
• Certification in Clinical Research (CCRP) or equivalent
• Experience in global clinical trials
• Experience in Phase 1 to 3 clinical trials, including rare disease and/or oncology
• Experience in all stages of clinical trial management, including study start-up, execution, and closeout

The salary range for this position is $145,000 - $160,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.