The Clinical Program Manager will be responsible for developing, managing and implementing single and multi-site clinical trials. This position is located in Emeryville and reports to the Director, Clinical Operations or VP, Clinical Operations.
- Develop and manage study timelines, milestones and budgets in collaboration with trial team members
- In collaboration with Medical Monitor, Medical Writer and relevant Subject Matter experts, 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
- May be responsible for mentoring junior staff (Clinical Research Associates, Clinical Trial Assistant, etc.) and/or be responsible for managing direct reports, as assigned.
- Minimum of a Bachelor of Science degree in a relevant scientific discipline
- 7+ years of related experience (biotech or pharmaceutical company), with a minimum 3 years experience managing external vendors (CROs).
- 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, 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; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to the conduct of clinical trials.
- Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
- Ability to travel – up to 20%
- Successful experience in a fast-pace entrepreneurial environment;
- Fit with Adamas culture and values
To apply for this position please send your resume to email@example.com with the job title in the subject line. Principals only, no recruiters please.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.