Clinical Trial Manager/Associate Director
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’re built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for a Clinical Trial Manager/Associate Director to join us in our Columbus, OH location and be part of our continued success!
About the role
The Clinical Trial Manager/Associate Director of Clinical Operations is responsible for the day-to-day management of clinical projects, including direct communication and interaction with clinical sites, and third-party vendors. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring; accountability of clinical monitoring compliance, tracking of critical project tasks; strategic study enrollment support including project-specific enrollment planning and project accountability. This role will work in our Columbus, OH office or remotely and will report to the Director, Clinical Operations.
Responsibilities and accountabilities
- Experienced clinical operations professional with proven track record of independently and effectively driving the planning and execution of operationally achievable study plans
- Able to efficiently manage complex clinical studies from concept through clinical study report completion
- Responsible for crafting clinical protocols, informed consent forms, investigational plans, study materials (e.g., training materials, case report forms, study files, supplies requirements)
- Participate in cross-functional teams to understand clinical program objectives within the broader business goals
- Execute to project objectives and workplans, including budgets and resource requirements
- Delegate assignments to functional area team members and track key project activities to successful completion
- Demonstrate ability to proactively identify and resolve product and project risks
- Ensure clinical research is conducted in accordance with FDA regulations, GCPs, ICH guidelines, international regulations and internal SOPs
- Evaluate and approve/qualify clinical sites to ensure compliance with applicable regulations
- Develop and track study budgets, including invoice review and accounting
- Manage and oversee site initiation and training for clinical study personnel at sites
- Manage on-going monitoring activities: scheduling, report review and approval
- Clinical study vendor management throughout the lifecycle of clinical studies
- Assist with negotiation and preparation of study contracts with clinical sites
- Support regulatory filings and submissions as they pertain to clinical study data
- Participate in the development and revision of Work Instructions, Guidance Documents, and Standard Operation Procedures (SOPs) as they relate to regular document maintenance or as a result of continuous improvement efforts
- Minimum of 3 years’ experience in clinical trial management; experience with neurological or gene therapy studies is preferred
- Bachelor’s and/or master’s degree in scientific discipline
- Extensive knowledge of FDA, international regulatory regulations, GCP, ICH guidelines and regulatory requirements for clinical trial management
- Strong computer literacy including proficiency in MS Project
- Strong written and verbal communication skills
- Prior experience in electronic data capture systems required
- Effective time management with ability to multi-task and maintain significant attention to detail
- Ability to organize and set priorities in a fast-paced environment and work independently with minimal supervision
Live an AskLife™
We offer a competitive total rewards package. Are you our next great discovery?