Associate Director Clinical Operations ( on-site )
Voyager Therapeutics is seeking an exceptional Associate Director, Clinical Operations, to partner closely with internal/external team members and vendors to ensure all assigned clinical trials are conducted per protocol, in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and established study budgets. This position reports to the Senior Director of Clinical Operations.
- Responsible for clinical operation timelines, and planning activities for each clinical study. Develop and mentor clinical staff and consultants, and secure sufficient resources to support the company’s goals and objectives.
- Ensure all functions, both internal and external are set up and managed to enable efficient start-up of sites
- Comprehensive oversight of day-to-day operational aspects of assigned clinical trial(s)
- Management of Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and project master files).
- Develop and /or review study related documents ( ie. consent forms, study manuals, study aids, etc. )
- Identify potential vendors, RFP proposal processes
- Works with CRO/ vendors to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensures that performance expectations are met.
- Drive consistent monitoring of study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
- Complete sponsor’s review of monitoring reports and periodic review of data quality.
- Identifying potential study issues, and proactively recommending and implementing solutions or corrective actions as needed.
- Assist with overall study budget development for new studies (e.g. CRO, Investigator fees, pass through fees) and providing information conjunction with the Finance Department
- Ensure budgets for external services are tracked by clinical operations to provide status regarding contract to budget actual
- Assist with budget forecasting and accruals as requested
- Act as primary resource for investigational sites; reviewing investigator contracts and site payments.
- 15 % travel to CRO/vendors facilities and/or investigative sites to train and assess study team and CRAs.
- Organizing and managing internal team meetings and other trial-specific meetings.
- Participate in ongoing development, review and implementation of departmental SOPs and processes.
- BS/BA degree in science or similar area.
- 8-10 years of experience required managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes including Electronic Data Collection (EDC) and Pharmacovigilance
Management of Phase I-III clinical trials, including multi-center, and multi-country registration trials
The ideal candidate will have a minimum of 5 years managing internal and external contract operations in the biotechnology industry desired.
Experience with compliance issues, corrective action procedures and strong understanding of FDA Regulations, GCP and/or SOPs in a clinical operations context
Excellent oral and written communications.
- Strong computer skills including knowledge of Microsoft Excel, Word, Powerpoint and Outlook.
- Ability to work within established timelines, in a fast paced environment.
- Excellent organizational and priority management skills.
- Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
- Prior CNS or gene therapy experience preferred.
- Travel up to 15% as needed ( Domestic/ Int’l )
Please no agency referrals, calls or unsolicited resumes accepted by Voyager Therapeutics