Clinical Trial Manager
About Voyager Therapeutics
Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging cutting-edge expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER™ AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc. and Sangamo Therapeutics, Inc., as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes wholly-owned and collaborative preclinical programs in Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and other diseases of the central nervous system, with a focus on validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com.
Voyager is growing as our organization moves forward into development and is seeking a Clinical Trial Manager (CTM) to join our evolving team. The CTM is an integral member of Voyager’s Development team, leading the planning, implementation, and management of early and late phase clinical research studies. The CTM is responsible for creating and managing study timelines, budgets, and study management plans in a fully outsourced model. This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review, and approve various study related documents and plans. This position offers the chance to join a team of passionate colleagues with the opportunity for career growth.
- Lead the cross-functional study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines
- Participate in the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
- Anticipate, recognize and resolve issues; as necessary, act as primary point of contact and manage escalation of study related issues
- Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports and ASRs/DSURs
- Review and approve study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
- Ensure appropriate clinical trial documentation including the trial master file
- Review monitoring reports to ensure quality and resolution of site-related issues
- Engage with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Monitor progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines
- Perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance as necessary
- Participate in the preparation and review of SOPs and other clinical operations initiatives
- Bachelor’s degree is required; scientific/health care field preferred.
- Minimum of 5 years in clinical development in pharmaceutical/biotech industry, 2+ years of expertise in clinical trial management
- Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
- Extensive experience managing complex protocols, CROs, 3rd party vendors, budgets, and timelines
- Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
- Ability to travel up to 15% as needed
- Ability to competently manage multiple competing priorities, adapting as needs change. Must be comfortable working in a fast-paced environment.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
- Strong communication skills and ability to work with and lead cross-functional study teams
- Ability to work independently and act with initiative to address issues