Senior Clinical Trial Manager, Clinical Operations

$175,000 - $175,000/Yr

Coherus Biosciences - Redwood City, CA

Full-time - Senior

Redwood City, CA

Professional, Scientific, and Technical Services

About the position

The Senior Clinical Trial Manager will play a pivotal role in the Coherus clinical team, overseeing the execution of clinical studies for various products. This position is designed for individuals with a strong background in clinical operations, particularly in managing complex Phase 1 studies, global Phase 2-3 studies, and post-marketing commitment studies. Depending on the complexity of the projects and the level of experience, the Senior Clinical Trial Manager may be responsible for managing one or more clinical studies or overseeing a multi-national region for multiple global clinical studies. The role involves close collaboration with contract research organizations (CROs), clinical laboratories, and other vendors, including clinical sites, to ensure that clinical studies are conducted efficiently, on time, and within budget. Additionally, the Senior Clinical Trial Manager will assist in developing processes and infrastructure within clinical operations to enhance overall efficiency and effectiveness. In this role, the Senior Clinical Trial Manager will act as the primary liaison to CROs and vendors for assigned clinical studies, ensuring adherence to project scope, deliverables, and timelines. The position requires organizing and facilitating study start-up activities, including the completion of essential clinical documents and agreements. The Senior Clinical Trial Manager will also be responsible for managing study logistics and monitoring activities, tracking clinical trial information, and reporting on patient recruitment and data cleaning status. The role may involve conducting monitoring visits and ensuring compliance with documentation requirements and Good Clinical Practice (GCP) regulations. Furthermore, the Senior Clinical Trial Manager will contribute to the development of clinical project timelines, clinical documents, and budgets, while also mentoring other clinical operations staff as needed.

Responsibilities

• Collaborate with other Coherus functional areas and consultants to coordinate assigned clinical study/program.
• Act as primary liaison to CROs and vendors for assigned clinical study/programs, ensuring adherence to project scope, deliverables, and timelines.
• Facilitate study start-up with CROs and clinical sites, including working closely with CRO to complete template clinical documents.
• Organize and run assigned clinical study team meetings and teleconferences.
• Manage study logistics and monitoring activities to ensure milestones and deliverables are achieved.
• Track and report clinical trial information and progress regarding patient recruitment and data cleaning status.
• Conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff.
• Ensure adherence to all documentation requirements and processes at the CRO(s) and within Coherus.
• Monitor the maintenance of the clinical trial master files per SOPs and GCP at the CRO(s) and vendors.
• 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 and study reports.
• 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.
• Assist in the development, forecasting, monitoring, and reporting of assigned clinical study/program budgets.
• Ensure compliance with Federal, State, and local regulations, GCP regulations, and internal SOPs.
• Act as primary liaison with clinical teams of development partners on assigned studies/program.
• Contribute to the writing and implementation of SOPs and study-specific guidelines.
• Manage or mentor other clinical operations staff as needed.
• Travel approximately 30% to domestic and international development partners, CROs, vendors, and clinical sites.

Requirements

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum of 5 years of experience in clinical trial management, preferably in a pharmaceutical or biotechnology setting.
• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Experience managing complex clinical studies, including Phase 1 and global Phase 2-3 studies.
• Proven ability to manage multiple projects simultaneously and meet deadlines.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong organizational skills and attention to detail.
• Experience with budget management and vendor negotiations.

Nice-to-haves

• Experience with post-marketing commitment studies.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Knowledge of statistical analysis and data interpretation.
• Experience in mentoring or managing junior staff.

Benefits

• Competitive salary between $140k and $175k per year.
• Comprehensive health insurance coverage.
• 401(k) retirement savings plan with company matching contributions.
• Paid time off and holidays.
• Opportunities for professional development and continued education.