Description
Clinical Program Manager - Clinical OperationsThe Clinical Program Manager will be responsible for developing, managing and implementing single and multi-site clinical studies. This position is located in Emeryville and reports to the Senior Director, Clinical Operations.
Specific responsibilities:
- Represent Clinical Operations as a member of trial teams.
- Develop study timelines, milestones and budgets in collaboration with trial team members.
- Develop study protocols with guidance from Medical Monitor.
- Develop case report forms, informed consent forms and other study-related documents.
- Selection and qualification of investigational sites.
- Participate in selection of, management and oversight of CROs and other vendors to ensure that clinical studies are executed properly, on time and in compliance with GCPs.
- Review and approve vendor and site invoices.
- Manage external resources, as required.
- Conducts site evaluations/initiation/monitoring and closeout visits, as required.
- Contributes to Clinical Study Reports, 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.
- Collect and archive documents for inclusion in the Trial Master File.
- Ensure study compliance by understanding and applying all relevant SOPs.
Qualifications:
- Minimum of a Bachelor of Science degree in a relevant scientific discipline
- 5 - 7 years experience (CRO or pharmaceutical company), with a minimum 2 years experience managing external vendors. Thorough knowledge of planning, implementing, and managing single and multi-center clinical trials is required. CNS experience is preferred and international study experience is a plus.
- Strong written and verbal communication, problem solving and negotiation skills.
- Good presentation skills: ability to present to diverse groups of clinical staff. 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; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies.
- Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
- Ability to travel