Coherus Biosciences, Inc. is focused on delivering high quality biosimilar therapeutics that will expand the access of important medicines to patients worldwide. Formed in 2010, Coherus has developed a unique, collaborative business model that leverages the leadership team’s deep product development expertise and the expertise of a network of strategic partners to develop therapeutics of the highest quality.
Our Company is currently looking for a Clinical Trial Manager. This is a newly created position located in Redwood City, California.
Description
Therapeutic Areas: Inflammation (Rheumatoid Arthritis, Psoriasis), and/or Oncology background preferred
This newly created position will work with others on our clinical team to manage the execution of global clinical studies for the Company’s various products. This position will assist in the management of contract research organizations, clinical laboratories, and other vendors, including clinical sites; will collaborate with clinical development partners as well as other internal departments to carry out successful clinical trials.
Primary Responsibilities and Duties:
• Act as primary liaison to CRO’s and vendors for assigned clinical studies/programs, providing Company representation and adherence to project scope, deliverables and timetables.
• Coordinate activities with the Company’s development partners, CRO and global clinical sites from study initiation to close out. Implement protocols with the CRO and ensure adherence to all documentation requirements and process.
• May act as primary liaison with clinical teams of development partners on assigned studies/programs.
• Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved.
• Collaborate with other functional areas and consultants, such as Drug Planning, Project Management, Finance, Quality Systems, and Regulatory Affairs in order to successfully coordinate assigned clinical studies/programs
• 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 trials/programs, etc.
• Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, Investigator Brochure, clinical study reports, INDs/CTA’s, NDA’s/MAA’s, annual regulatory reports, etc.
• Assist in the development, forecasting, monitoring, and reporting of assigned clinical trial budgets
• Assist in the development of clinical project timelines to meet critical company milestones; recognize and escalate issues that may jeopardize timelines and deliverables, or lead to out of scope expenses.
• May coordinate RFP process, review vendor proposals, and negotiate clinical budgets for assigned trials/programs.
• 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, vendor qualification visits, routine study visits, trial master file review visits, etc.
• Monitor the maintenance of the clinical trial master files per SOPs and GCP, maintained at CRO. Review clinical study files for completeness periodically throughout and at the completion of clinical trials and prior to archiving. Set-up and manage CTMF in-house for assigned study.
• Organize and run assigned clinical study team meetings and teleconferences.
• Facilitate study start up with CROs and clinical sites as necessary, including, work with CRO to complete template clinical documents, such as, ICF, source document worksheets, CRF specifications, and CRF documents, clinical site agreement, and other study documentation.
• Contribute to the writing and implementation of Standard Operating Procedures (SOPs) and standard forms to support clinical operations, and study-specific guidelines
• Work with other internal staff to ensure clinical trials are completed in compliance with FDA regulations, ICH guidelines for Good Clinical Practices (GCP) and the conduct of clinical trials.
• Travel as required to domestic and international development partners, CRO’s, vendors, and clinical sites, as needed, approximately 40%.
BA/BS and direct relevant experience in global drug development required, advanced degree (MS) in a life science major is preferred.
• 5-7 years of experience of biotech/pharmaceutical clinical operations experience
• Must have experience in managing the execution of complex phase 1-3 global clinical trials, preferably in inflammation or oncology-related clinical therapeutic areas
• Strong experience in CRO and vendor management to support global clinical trials
• Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
• Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR’s, regulatory documents (including IND/CTA, NDA/MAA documents and annual/periodic updates).
• Understanding of data management, statistics and medical writing processes for clinical development.
• Team-oriented with excellent communication and interpersonal skills demonstrated ability in managing indirectly
• Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals
• 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.
• 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.
Our Company offers excellent benefits including medical, dental, vision, life, short and long term disability plans, 401k, FSA, vacations, paid holidays and health club reimbursement. If you would like to join a innovative start-up please send your resume to [email protected].