ZipRecruiter
Sr. Clinical Trial Manager, Clinical Operations (Early Phase)
ZipRecruiter, Thousand Oaks, California, United States, 91362
Job DescriptionJob DescriptionSalary: $160,000 - $190,000
Job: Sr. Clinical Trial Manager, Clinical Operations (Early Phase)
Location: Thousand Oaks, CA or San Francisco, CA
Position type: Full Time Reports to: Senior Director, Clinical Operations
Position Summary Reporting to the Senior Director, Clinical Operations, the Sr. Clinical Trial Manager (Sr. CTM) will be responsible for the day-to-day management and execution of assigned clinical trials, including study startup, subject recruitment, study conduct, and study close-out. This individual will perform required job duties with minimal guidance to ensure that trial timelines, budget, and quality metrics are met, and that the trials are conducted in compliance with the protocol, SOPs and applicable regulatory requirements. The ideal candidate has strong communication and project management skills, be agile and able to work effectively in a fast-paced environment, and has prior experience leading early phase clinical trials and healthy volunteer studies.
Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area. In-office presence is required.
Primary responsibilities include (but are not limited to):
Lead the cross-functional trial execution team to ensure that study deliverables and milestones are met.
Manage all aspects of clinical study execution, including oversight and day-to-day management of CROs and other service providers (bioanalytical lab, cardiac safety lab, IRT, etc.) as required.
Ensure clinical studies are conducted in compliance with SOPs, ICH/GCP guidelines, and FDA regulations. Ensure quality of clinical execution and trial data.
Accurately manage study budgets, including accruals reporting and forecasting, invoice review, and oversight of investigator grants.
With key stakeholders and subject matter experts, coordinate the development of the clinical study protocol, as required.
Provide operational input into the development of the clinical study protocol, informed consent form, case report forms, and other study-level documents.
Direct or lead the development of study plans, operational manuals, site training materials, and other study tools with the CRO.
Participate in vendor identification and selection, including development of RFPs, assessment of service provider capabilities, and vendor contract and budget negotiations.
Ensure selection of qualified investigators and sites. Conduct site and CRO evaluation visits, as required.
Provide site, CRO, and vendor training.
Perform co-monitoring and sponsor oversight visits, as needed.
Facilitate negotiation and finalization of investigator site agreements and budgets.
Ensure the proper set up and maintenance of the Trial Master File (TMF), including periodic review.
Initiate and maintain any locally required clinical trial registries (e.g., clinicaltrials.gov) for assigned studies.
Proactively identify, communicate, and remediate study issues.
Accurately track and report on key study activities (eg., country startup, site activation, patient recruitment, patient status, data collection, data review, etc.). Maintain study metrics for routine reporting to the internal project team and leadership.
Participate in development and/or review of department SOPs.
Up to 20% travel may be required, consistent with project needs.
Qualifications:
Bachelors Degree in life sciences
5+ years relevant industry experience, with demonstrated proficiency in clinical trial execution and management
Prior experience managing Phase 1 healthy volunteer and clinical pharmacology studies .
Proficient knowledge of ICH GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
Prior experience with vendor selection and management
Demonstrated critical thinking, problem solving, and negotiation skills
Demonstrated ability to successfully work in cross-functional project teams with an emphasis on teamwork, collaboration, and communication.
Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines.
Job: Sr. Clinical Trial Manager, Clinical Operations (Early Phase)
Location: Thousand Oaks, CA or San Francisco, CA
Position type: Full Time Reports to: Senior Director, Clinical Operations
Position Summary Reporting to the Senior Director, Clinical Operations, the Sr. Clinical Trial Manager (Sr. CTM) will be responsible for the day-to-day management and execution of assigned clinical trials, including study startup, subject recruitment, study conduct, and study close-out. This individual will perform required job duties with minimal guidance to ensure that trial timelines, budget, and quality metrics are met, and that the trials are conducted in compliance with the protocol, SOPs and applicable regulatory requirements. The ideal candidate has strong communication and project management skills, be agile and able to work effectively in a fast-paced environment, and has prior experience leading early phase clinical trials and healthy volunteer studies.
Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area. In-office presence is required.
Primary responsibilities include (but are not limited to):
Lead the cross-functional trial execution team to ensure that study deliverables and milestones are met.
Manage all aspects of clinical study execution, including oversight and day-to-day management of CROs and other service providers (bioanalytical lab, cardiac safety lab, IRT, etc.) as required.
Ensure clinical studies are conducted in compliance with SOPs, ICH/GCP guidelines, and FDA regulations. Ensure quality of clinical execution and trial data.
Accurately manage study budgets, including accruals reporting and forecasting, invoice review, and oversight of investigator grants.
With key stakeholders and subject matter experts, coordinate the development of the clinical study protocol, as required.
Provide operational input into the development of the clinical study protocol, informed consent form, case report forms, and other study-level documents.
Direct or lead the development of study plans, operational manuals, site training materials, and other study tools with the CRO.
Participate in vendor identification and selection, including development of RFPs, assessment of service provider capabilities, and vendor contract and budget negotiations.
Ensure selection of qualified investigators and sites. Conduct site and CRO evaluation visits, as required.
Provide site, CRO, and vendor training.
Perform co-monitoring and sponsor oversight visits, as needed.
Facilitate negotiation and finalization of investigator site agreements and budgets.
Ensure the proper set up and maintenance of the Trial Master File (TMF), including periodic review.
Initiate and maintain any locally required clinical trial registries (e.g., clinicaltrials.gov) for assigned studies.
Proactively identify, communicate, and remediate study issues.
Accurately track and report on key study activities (eg., country startup, site activation, patient recruitment, patient status, data collection, data review, etc.). Maintain study metrics for routine reporting to the internal project team and leadership.
Participate in development and/or review of department SOPs.
Up to 20% travel may be required, consistent with project needs.
Qualifications:
Bachelors Degree in life sciences
5+ years relevant industry experience, with demonstrated proficiency in clinical trial execution and management
Prior experience managing Phase 1 healthy volunteer and clinical pharmacology studies .
Proficient knowledge of ICH GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
Prior experience with vendor selection and management
Demonstrated critical thinking, problem solving, and negotiation skills
Demonstrated ability to successfully work in cross-functional project teams with an emphasis on teamwork, collaboration, and communication.
Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines.