Clinical Trial Manager/Senior Clinical Trial Manager
In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.
Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.
We are located in the San Francisco bay area, in the heart of the world’s largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.
The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. Remote-based is optional depending on prior experience. This position is remote or in-house, depending on prior experience. This position will report to a Clinical Program Director. Any in-house positions for this role will begin home-based until offices are opened to normal operating procedures.
Responsibilities may include, but are not limited to:
- Day-to-day management of assigned operational aspects, including but not limited to vendor/ laboratory management, oversight of clinical sites, etc.
- Obtains and reviews all required essential documents necessary for study/site initiation
- Maintains accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
- Manages and tracks patient enrollment for complex clinical trials
- Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs
- Supports and may lead the development and review of clinical study plans, presentations or study-related documents
- Supports in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT
- Assists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed
- Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
- May perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and study plans, as required
- Reviews monitoring trip reports and track resolution of all action items
- Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
- Assists with providing oversight of CROs and vendors
- Coordinates with CRO and PM in clinical site oversight, data entry timeliness, assists with resolving site issues
- Assists with set-up and review of clinical trial TMF
- Mentoring junior team members
- Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested
- Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable
- Recommends and implements innovative ideas to increase efficiency and quality of program management activities
- Bachelor’s degree, preferably in a scientific field
- Minimum 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology
- Demonstrates core understanding of medical terminology and clinical trial activities
- Thorough understanding of ICH GCP guidelines
- Understanding of clinical trial processes from study start-up through study closure
- Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
- Excellent planning and organization skills
- Self-motivated, assertive, and able to function independently and as part of a team
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
- Proven problem solving and decision-making skills
- Excellent IT Microsoft skills and experience using clinical trial management we-based systems (i.e. EDC, IRT, CTMS, eTMF, etc)
- Ability and willingness to travel 10-20% (domestic and international)