Coherus BioSciences
Senior Clinical Project Manager
Redwood City, CA, United States · Senior
Sponsorship not specifiedDetected 4410 days ago
GCPStatisticsProject ManagementForecastingExcelLogisticsVendor ManagementClinical TrialsFDA RegulatoryResearchLeadershipCommunicationCollaborationMicrosoft OfficeRegulatory Affairs
About the role
- 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 also assist with the development of processes and infrastructure within clinical operations.
- 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.
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.
- 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.
- 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.
- 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.
- Set-up and manage necessary portions of the trial master file in-house for assigned clinical study/program.
- Strong experience in CRO and vendor management to support global clinical trials
- Perform other related tasks as requested.
Requirements
- Travel as required to domestic and international development partners, CROs, vendors, and clinical sites, as needed, approximately 30%.
- Must have experience in managing the execution of complex Phase 1 and global Phase 3 clinical trials, preferably in inflammation or oncology-related therapeutic areas.
- Excellent knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
- At least 10 years of experience of biotech/pharmaceutical clinical operations experience with 5 in a clinical trial management role; CRO experience a plus.
Nice to have
- BA/BS (life science major preferred) and/or nursing degree and/or pharmacy degree required.
- At least 10 years of experience of biotech/pharmaceutical clinical operations experience with 5 in a clinical trial management role
- CRO experience a plus.
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/CTAs, marketing applications, annual regulatory reports, etc.
Benefits
- Understanding of data management, statistics and medical writing processes for clinical development.
Company info
- Assist in the development of clinical project timelines to meet critical company milestones.
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