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Clinical Trials Manager
The incumbent is accountable for the day-to-day management of Lyell’s clinical studies and for ensuring the studies are delivered on time, within budget, with high quality data, and in compliance with the protocol, standard operating procedures, good clinical practice guidelines, and other applicable laws and regulatory requirements. The incumbent will manage the cross-functional clinical study implementation team for assigned studies and will be accountable for managing day-to-day activities of CROs and clinical Vendors.
KEY ROLE AND RESPONSIBILITIES:
- Lead the development of overall strategic planning for assigned clinical trials including timelines, budgets, CRO/vendor oversight plans, key deliverables, and risk/mitigation strategy.
- Assessing the operational feasibility and recommendations on the study execution plan; assist in developing and managing comprehensive clinical study timelines, metrics, budgets; provides study-specific training and leadership to clinical research staff.
- Prepare and present project debriefings, as required.
- Plan, execute, and lead study-specific meetings.
- Monitor the overall CRO/vendor performance and study health as it relates to timelines, budgets, and quality, and ensure all clinical study deliverables are met in accordance with the timeline, budget, and resource requirements as well as in compliance with relevant regulations and guidelines.
- Identify potential study issues, and ensure optimization of performance, delivery of scoped services, resources, expertise, and knowledge.
- Responsible for ensuring that CRO and Clinical Project Team delivers timely and satisfactory Project deliverables with high quality.
- Leverage operational and therapeutic expertise to optimize trial design and execution.
- Review list of approved sites for selection visits.
- Plan and allocate clinical team resources.
- Determine, develop, and implement tracking and reporting specifications.
- Work with the study team to design clinical protocol; provide input for the design of the ICF template, source documents and CRFs.
- Prepare and/or review study-related documents to include clinical logs, forms, manuals, and guidelines.
- Track and manage subject recruitment at all study sites.
- Oversee the management of study monitoring visits, and the review and approval of monitoring reports.
- Monitor site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud, and negative trends. Ongoing protocol deviation tracking, reporting, and trending.
- Notify CRO and sites of updates on global study information.
- Oversee the collection, review and filing of site essential documents, and maintenance of the TMF.
- Coordination of intellectual property and clinical study supplies and oversee overall tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS.
- Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.
- Lead and own formal risk assessment activities; review and approve corrective action plans across study, participate in the planning of quality assurance activities, internal and external audits/inspections and coordinate resolution of audit/inspection findings.
- Mentoring of all clinical operations staff, to include coaching and providing guidance to them about clinical trials.
- Daily interaction with Clinical Operations management and members of the cross-functional study team.
- Lead the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigators Sites, vendors, etc.).
- Lead and partake in regular team meeting / teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Investigator Meetings as necessary.
- Communicate any out-of-scope issues to upper management as soon as identified.
- Bachelor’s Degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field with 10+ years of clinical research experience.
- Demonstrated experience managing effectively in a clinical environment
- Extensive experience working with clinical protocols
- An experienced, strong collaborator, effective at influencing internally and externally, and proactive in a fast-paced environment
KNOWLEDGE, SKILLS AND ABILITIES:
- Oncology Experience
- Cell therapy Experience
- Excellent verbal and written communication skills required.
- Excellent organizational, multi-tasking and time management skills required.
- Sound knowledge of medical terminology and clinical trial management process.
- Knowledge of FDA regulations and International Council for Harmonization Good Clinical Practice guidelines.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.