Job Title: Senior Clinical Trial Manager
Department: R&D: Clinical Operations
Reports To: V.P., Head of Operations
FLSA Status: Exempt
Location: San Diego or Remote
Summary
The Senior Clinical Trial Manager (Sr. CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs. The Sr. CTM leads the cross-functional clinical trial team and 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.
Responsibilities
- Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial 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 (CTM) label review and approval and assisting with CTM 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 the protocol, table, figure, data listings, and clinical study report reviews
- Provides input/reviews DSUR, PSUR, 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
- Demonstrates interpersonal versatility, able to simultaneously serve as an individual contributor and a leader
- Thinks strategically and tactically
- Ability to manage trial(s) independently with minimal oversight
- Leads through influence with the ability to manage and mentor internal personnel and external resources
- Participates in the identification and selection process for CROs and vendors
- Provides input on protocol design and statistical analysis plan (SAP)
- Mentors less experienced Clinical Trial Managers and Clinical Operations team members; assists with team development
Qualifications
- Bachelor’s degree
- 8+ years of relevant and progressive clinical trial management experience
- Experience in full-cycle drug development
- Strong understanding of clinical trials processes, protocols, and medical terminology
- Strong experience utilizing CTMS, EDC, TMS, and related software
- Prior experience in management and monitoring of CRO and investigative sites
- Strong experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability, and budget management
- Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority drug research & development regulations
- Advanced experience with bio-samples, storage of 3rd party data
- Motivated to work in a fast-paced, high-accountability environment
- Travel up to 25%
“Pay Transparency”
The salary range for candidates who work in La, Jolla, CA is $155-171K. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
“Benefits”
Employees (and their families) are eligible for medical, dental, vision, and basic life insurance. Employees can enroll in our company’s 401k plan which currently includes matching up to 4% of earnings to IRS limits. Employees are also eligible for unlimited paid time off. Employees also currently enjoy paid time off for federal holidays and company closures for a week in August and a week in December each year. Benefits are subject to change.
“Other compensation”
Hired applicants will be granted stock options and may be eligible for annual bonuses.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Senior Clinical Trial Manager – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)
