Senior Clinical Trial Manager, Clinical Operations

$140,000 - $175,000/Yr

Coherus Biosciences - Redwood City, CA

Full-time - Senior

Remote - 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 critical for 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 on time and within budget. Additionally, the Senior Clinical Trial Manager will assist in developing processes and infrastructure within clinical operations to enhance 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 facilitating study start-up with CROs and clinical sites, which includes working closely with CROs to complete essential clinical documents such as informed consent forms (ICF), source document worksheets, and clinical site agreements. The Senior Clinical Trial Manager will also organize and run clinical study team meetings and teleconferences, manage study logistics, and monitor activities to ensure that milestones and deliverables are achieved. Recognizing and escalating issues that may jeopardize timelines or lead to out-of-scope expenses is a key responsibility. The role also involves tracking and reporting clinical trial information, conducting monitoring visits, ensuring adherence to documentation requirements, and maintaining clinical trial master files. The Senior Clinical Trial Manager will contribute to the development of clinical project timelines, write or contribute to clinical documents, coordinate the RFP process, and assist in budget development and monitoring. Compliance with federal, state, and local regulations, as well as Good Clinical Practice (GCP) regulations, is essential. The position may also involve mentoring other clinical operations staff and requires travel to domestic and international sites, approximately 30%.

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 completing template clinical documents and agreements.
• 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 as necessary.
• Ensure adherence to all documentation requirements and processes at the CRO(s) and other vendors.
• Monitor the maintenance of the clinical trial master files per SOPs and GCP.
• Assist in the development of clinical project timelines to meet critical company milestones.
• Write or contribute to the development of clinical documents such as protocols and study reports.
• Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned studies.
• 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 regulations and internal SOPs during clinical studies.
• Contribute to the writing and implementation of SOPs and study-specific guidelines.
• May manage or mentor other clinical operations staff.
• Travel as required to domestic and international development partners, CROs, vendors, and clinical sites.

Requirements

• BS in life sciences or equivalent work experience.
• 10+ years of experience in biotech/pharmaceutical clinical operations, with at least 7 years in a clinical trial management role.
• Experience in managing the execution of complex and/or global clinical trials, particularly in oncology-related therapeutic areas.
• Strong experience in CRO and vendor management to support global clinical trials.
• Excellent knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
• Demonstrated skills in writing/reviewing clinical study protocols, CRF designs, and regulatory documents.
• Understanding of data management, statistics, and medical writing processes for clinical development.
• Ability to contribute results to clinical operations and company-wide goals.
• Team-oriented with superior verbal and written communication skills.
• Ability to meet short-term deadlines and multi-task in a fast-paced work environment.
• Ability to motivate a team to work effectively in a changing environment.
• Demonstrated computer skills using MS Office Suite.

Nice-to-haves

• Experience in oncology-related therapeutic areas is preferred.
• Familiarity with international clinical trial regulations and practices.

Benefits

• Competitive salary range of $140,000 - $175,000 based on experience.
• Equal employment opportunities and a commitment to diversity and inclusion.
• COVID-19 vaccination requirement for new hires with accommodation options available.