Coherus BioSciences
Clinical Trial Manager
Redwood City, CA, United States
Sponsorship not specifiedDetected 4572 days ago
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About the role
- Coherus Biosciences, Inc. is focused on delivering high quality biosimilar therapeutics that will expand the access of important medicines to patients worldwide.
- Our Company is currently looking for a Clinical Trial Manager.
- This is a newly created position located in Redwood City, California.
Responsibilities
- 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.
- 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
- 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.
- Set-up and manage CTMF in-house for assigned study.
- 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
- Strong experience in CRO and vendor management to support global clinical trials
Requirements
- Travel as required to domestic and international development partners, CRO's, vendors, and clinical sites, as needed, approximately 40%.
- 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
Nice to have
- Inflammation (Rheumatoid Arthritis, Psoriasis), and/or Oncology background preferred
- This position will assist in the management of contract research organizations, clinical laboratories, and other vendors, including clinical sites
Compensation
- 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.
- 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).
Benefits
- Understanding of data management, statistics and medical writing processes for clinical development.
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