ORIC Pharmaceuticals
Description
The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The individual will be primarily responsible for quality for clinical activities, including but not limited to conducting clinical monitoring, study site management and ensuring compliance with SOPs, GCPs and ICH guidelines. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives as required.
Responsibilities
- Manages all clinical aspects of study under oversight of the Clinical Operations Lead, including but not limited to initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and pharmacy manuals, etc.), plans and manages study-specific meetings (e.g. Study Team Meetings, etc).
- Execute clinical monitoring, site initiation and close out visits in adherence to GCPs and ensure studies are in compliance with study protocol, appropriate SOPs and ICH/GCP regulations and study-specific manuals and procedures and write/revise the relevant reports, as necessary.
- Ensures clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations including but not limited to participate in the planning of quality assurance activities and coordinate resolution of audit findings; ensure audit-ready condition of clinical trial documentation; review monitoring reports to ensure quality and resolution of site-related issues; work with QA for CAPA documentation and resolution.
- Manages the study submission to IRB/ECs in coordination with CRO, as appropriate.
- Assist in the selection activities for external vendors and is responsible for the management/oversight of external vendors including but not limited to the development of vendor specifications; review vendor reports, budgets, and metrics.
- Provides study-specific training and delivers Sponsor’s guidance to clinical research staff, including CRO, CRAs, sites and other contract personnel.
- Verify monthly accruals from vendors and study sites, investigator contracts and payments, as necessary.
- Monitor the progress of trials including enrollment, laboratory samples management, and clinical trial material inventory.
- Participate in data cleaning and database lock; review and identify trends in enrollment and data entry at sites and proactively interface with CRO’s clinical monitoring team.
- Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring trip reports.
- Oversight of TMF management and review TMF document as necessary.
- Provide study updates at clinical operations meetings-including updating other clinical staff and upper management on patient recruitment, trial issues, investigator’s feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues.
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Experience
- BA/BS with science major, or an equivalent combination of education and related experience
- At least 5 years of relevant clinical trial management and 2+ years as clinical research associate with on site/remote clinical monitoring experience in the pharmaceutical/biotechnology company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3) – Oncology therapeutic indication ideal.
- Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities.
- Must be able to thrive in an entrepreneurial, fast-paced, and dynamic work environment.
- Must be organized and be able to communicate effectively.
- Experience in practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
- Experience with electronic data capture and data management software.
- Excellent oral and written communication skills.
- Up to 25% travel.
