Title: Senior Clinical Trial Manager, Clinical Operations
Reports To: Executive Director, Clinical Operations
Location: Redwood City, California
This position will work with the Coherus clinical team to manage execution of clinical studies for Coherus’ various products. The position will either focus on complex Phase 1 studies, global Phase 2-3 studies, and/or post marketing commitment studies. 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. This position will 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. This position will also assist with the development of processes and infrastructure within clinical operations.
Principal Responsibilities and Duties:
- 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; recognize and escalate issues that may jeopardize timelines and deliverables, or lead to out of scope expenses.
- 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.
- Ensure adherence to all documentation requirements and process at the CRO(s), all other vendors and within Coherus.
- 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.
- May act as primary liaison with clinical teams of development partners on assigned studies/program.
- 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.).
- Travel as required to domestic and international development partners, CROs, vendors, and clinical sites, as needed, approximately 30%.
Background and Experience:
- BS in life sciences, or equivalent work experience.
- 10+ years of experience of biotech/pharmaceutical clinical operations experience with at least 7 in a clinical trial management role.
- Must have experience in managing the execution of complex and/or global clinical trials, 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, CSRs, regulatory documents (including IND/CTA, marketing application documents and annual/periodic updates) and developing study documentation.
- Understanding of data management, statistics and medical writing processes for clinical development.
- Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals
- Team-oriented with superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
- Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.
- Able to motivate a team to work effectively in a changing and fast-paced environment
- Ability to travel domestically and internationally. Some travel will take place on/over weekends.
- Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, MS Outlook, and MS Project) software.
- Perform other related tasks as requested.
The Base Salary Range for this position is $135,000 - $170,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.