Our client is seeking a CONTRACT- Clinical Program Manager. Reporting to the Vice President of Clinical Operations, the Clinical Program Manager will be responsible for developing, managing and implementing single and multi-site clinical trials or a suite of studies to required quality standards, ensuring the integrity of the clinical data on schedule and within budget for phase I-IV clinical trials by supervising outside vendors and contractors.
- Develop and manage study timelines, milestones and budgets in collaboration with trial team members
- Will help develop study concepts & protocols
- Develop case report forms, informed consent forms and other study-related documents
- Manage the selection process and, when needed, conduct qualification of investigational sites
- Participate in selection of, management and oversight of CROs and other vendors to ensure that clinical trials are executed properly, on time and in compliance with GCPs
- Review and approve vendor and site invoices
- Manage external resources, as required
- Conducts and/or delegates, site evaluations/initiation/monitoring and closeout visits, as required
- Leads development of Clinical Study Reports, contributes to NDAs, and other clinical/regulatory/safety documents.– ensuring reports are controlled for quality, signed off and published with copies going to Regulatory Authorities and Ethics Committees, as required
- Oversees collection and archival of all necessary documents for inclusion in the Trial Master File
- Ensure study compliance by understanding and applying all relevant SOPs
- Minimum of a Bachelor of Science degree in a relevant scientific discipline
- 10+ years of related experience (biotech or pharmaceutical company) managing external vendors (CROs).
- Thorough knowledge of planning, implementing, and managing single and multi-center clinical trials is required. Experience in gene therapy, therapeutic proteins and monoclonal antibodies is a huge plus.
- Strong written and verbal communication, interpersonal, problem solving and negotiation skills
- Good presentation skills: ability to present to diverse groups of clinical staff (internal and external) Proven organizational skills; ability to manage multiple priorities and work under pressure
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314 is a plus.
- Ability to travel – up to 20%
- Successful experience in a fast-pace entrepreneurial environment