Job Title: Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM)
Job Type: Full Time, Exempt
Salary: $140K – $180K annually
Job Summary
This is a full-time position required to work at PeproMene’s office located in Irvine, California, reporting directly to the Chief Operating Officer. The Clinical Trial Manager or Senior Clinical Trial Manager (CTM or Sr. CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The Sr. CTM partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to: CRO and vendor selection, contracting and management; inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments; reporting and metrics; and safety events and reporting.
General Responsibilities*
- Leads the cross-functional team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
- Responsible for clinical trial material label review and approval and assisting with clinical trial material forecasting
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues appropriately in a timely manner
- Obtain and relay key study issues, status updates and other study information to the clinical trial team and management
- Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Provides input on the development of eCRF design
- Participates in IRT, EDC and ePRO user acceptance testing
- Participates in data cleaning, listing, and report output reviews
- Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials
- Participates in protocol deviation listing reviews and meetings
- Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments
- Participates in protocol, table, figure, data listings and clinical study report reviews
- Provides input/reviews DSUR and regulatory annual and periodical reports
- Develops presentations for clinical sites, team and investigator meetings
- Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
- May be responsible for a defined region, vendor or process across a program
- May have functional reporting responsibilities
- Performs other work-related duties as assigned or required
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Bachelor’s degree in a scientific discipline
- 10+ years of clinical operations experience including 5+ years as a Clinical Trial Manager, working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology and antibody/biologics experience
- Experience in full-cycle drug development
- Strong understanding of clinical trials processes, protocols and medical terminology
- Strong experience utilizing CTMS, EDC, eTMF and related software
- Strong experience in management and monitoring of CRO and investigative sites
- Experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management
- Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations
- Experience with bio-samples, storage of 3rd party data
- Motivated to work in a fast-paced, high accountability environment
- Travel up to 25%
