Senior Clinical Trial Manager, Clinical Operations

4 weeks ago

Redwood City, California, United States Coherus BioSciences Full time
Clinical Operations Senior Manager, Clinical Trial

This position will work with the Coherus clinical team to manage the execution of clinical studies for Coherus' various products. Depending on project complexity and level of experience, this may include managing one or more clinical studies and/or managing a multi-national region for multiple global clinical studies.

Key Responsibilities:

• Assist in the management of contract research organizations (CROs), clinical laboratories, and other vendors, including clinical sites; collaborate with clinical development partners, as well as other internal departments to ensure that the clinical studies are conducted on time and within budget.

• Collaborate with other Coherus functional areas and consultants, such as Drug Planning, Project Management, Finance, Quality Systems, and Regulatory Affairs in order to successfully coordinate assigned clinical study/program.

• Act as primary liaison to CROs and vendors for assigned clinical study/programs, providing Coherus representation and ensuring adherence to project scope, deliverables and timelines.

• Facilitate study start up with CROs and clinical sites as necessary, including, working closely with CRO to complete template clinical documents, such as, ICF, source document worksheets, CRF specifications and development, clinical site agreements, and other study documentation.

• Organize and run assigned clinical study team meetings and teleconferences.

• Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved; Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD/ADA) data, data cleaning status for assigned clinical study/program, etc.

• May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff, and/or with compliance personnel, including pre-study qualification visits, site initiation visits, eligibility review visits, routine study visits, trial master file review visits, vendor qualification or selection visits, etc.

• Monitor the maintenance of the clinical trial master files per SOPs and GCP, at the CRO(s) and vendors. Review clinical study files for completeness periodically throughout and at the completion of clinical trials and prior to archiving. Set-up and manage necessary portions of the trial master file in-house for assigned clinical study/program.

• Assist in the development of clinical project timelines to meet critical company milestones.

• Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, Pharmacy Manual, investigator brochure, clinical study reports, INDs/CTAs, marketing applications, annual regulatory reports, etc.

• Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned clinical study/program.

• Assess feasibility for assigned clinical studies and contribute to the investigator/site selection process.

• In collaboration with Finance, assist in the development, forecasting, monitoring, and reporting of assigned clinical study/program budgets.

• In collaboration with other Coherus clinical staff and departments ensure the clinical studies are conducted in compliance with Federal, State and local regulations, Good Clinical Practice regulations and internal Standard Operating Procedures.

• Contribute to the writing and implementation of Standard Operating Procedures (SOPs), standard forms and study-specific guidelines to support clinical operations.

• May manage or mentor other clinical operations staff (i.e. in-house CRAs, CTAs, etc.).

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