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Clinical Trial Manager
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MEIRxRS / Med Exec Intl
Posted on Aug 1
Phase I company needs a Clinical Trial Manager/Clinical Project Manger to manage the day-to-day operations of the company’s cell-therapy clinical trials and associated projects. Company is open to W-2, contract and contract to hire. This position is onsite at the company HQ in Menlo Park, CA.
5+ years of experience in clinical research and/or clinical trial operations with a strong track record of successful trial initiation and execution. Sponsor (industry) organization experience is strongly preferred.
Comprehensive understanding of applicable clinical research regulations. Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
Experience managing vendors, including performance assessments and financial management (invoice review, change order management, budget forecasting, etc.).
Working experience with EDC and CTMS systems.
Able to work effectively under a fast-paced and changing environment.
Strong work ethic and demonstrated ability to deliver assignments on time.
Excellent verbal and written communication and presentation skills.
Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.
Ability to travel as required (up to 50%).
Clinical Operations Manager
As Clinical Operations Manager, you will manage the day-to-day operations of the company’s clinical studies and associated projects. Your key accountabilities include the coordination of daily activities associated with the setup and management of a clinical trial in compliance with SOPs, regulations, and ICH/GCP guidelines. You will act as the interface with the cross-functional project team (medical, regulatory, manufacturing and other key functions) both internally and externally (CRO) to ensure successful support of all clinical activities and project deliverables within the required time frame and budget.
Manage clinical operational aspects of study, including assessment of feasibility, management of study timelines and metrics, study-specific training of staff, study-specific meetings, and EDC monitoring of study data.
Track and coordinate CRO and third-party vendor activities through key metrics, so we can maintain oversight of clinical programs. Manage costs, deliverables and quality of the respective study activities.
Ensure that all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOPs.
Prepare study-related documents (e.g., site-specific informed consent, investigator contracts, study tools/worksheets, monitoring plan, site monitoring report, etc.) and assist with submission.
Provide operational insights into clinical trial design, including clinical protocols, amendments, informed consent forms, study guides, case report forms.
Be a subject matter expert on clinical operations and assist in the training of CRAs, CTAs and CRO personnel on protocols and practices.
Play a key role in planning, management and execution of internal team meetings, investigator meetings, review boards, and other study specific meetings.
Track site payments and CRO/third-party vendor invoices in collaboration with Finance.
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