Compassionate Use, Investigator Sponsored Trial (IST) Manager
The Investigator Sponsored Trial (IST) Expanded Access Program (EAP) Manager will serve a key role in the Medical Affairs organization. The primary responsibility of this position is to provide operational oversight and management of ISTs as well as support the EAP program ensuring key program milestones are met, program updates are communicated in a meaningful and useful way to key stakeholders across the organization. As the key person responsible for the IST and compassionate use programs, you will be at the forefront of the company’s efforts to expand research and provide lifesaving treatments to patients working closely with the internal teams across all aspects of the programs, including investigators and expanded access protocol providers as well as clinical development, pharmacovigilance, regulatory, compliance, manufacturing, and other areas as appropriate.
- This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
Responsibilities
IST program
- Act as the central contact for designated project communications, correspondence, and associated documentation for assigned ISTs.
- Maintain communication with the Sponsor-Investigator and staff during all phases of the IST regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents.
- Monitor study progress and initiate corrective and preventative actions when the trial deviates from plans, communicate study progress and issues to IST team members in support of Medical Affairs/R&D.
- May provide operational input to preparation of IST proposal documents, Request for Service (RFS) processes, and ensuring that contracts, budgets and payment schedules as well as drug management are prepared and followed in accordance with IST contract requirements.
- Ensure that required safety information is reported and processed according to all applicable SOPs.
- Maintain documentation of assigned ISTs and perform periodic review to ensure accuracy and completeness
- Develop therapeutic knowledge to support roles and responsibilities.
- Participate in preparing for or conducting internal audits or in case of Health Authority inspections.
- Ensure quality oversight and support of assigned ISTs utilizing available tools.
EAP (Compassionate Use)
- Manage Individual Patient Expanded Access (IPEA) requests globally and associated expanded access mailbox ensuring appropriate triage and approvals are routed and documented per policy.
- Responsible for the oversight and review of data captured by Expanded Access Protocol vendor for the program and trouble shooting.
- Build and maintain the expanded access protocol team data repository system and sharepoint folders; provide metrics, invoice and financial tracking and reporting on EAP status
- Manage daily activities of the vendor selected for the expanded access protocol and ensure, for example, Master Services Agreement (MSA), Statement of Work (SOW) and other relevant documentation are completed, successfully executed, and updated as needed
- Partner with appropriate Medical functional contacts to develop training materials, and provide training to appropriate team members and stakeholders on program objectives, timelines, etc.
- Participate and present in regular team meetings with selected vendors to track progress and outcomes, as appropriate.
- Responsible for compiling meeting minutes at all EAP team led meetings
Qualifications
Education and Experience:
- Bachelor’s degree required, preferable in Life Sciences or Nursing (BSN)
- Minimum of 4 years of progressive experience in a pharmaceutical company, biotech company or CRO
- Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner with limited direction
- Ability to establish and foster effective communication and relationships with investigators, vendors, and internal colleagues that support and advance trial team goals and objectives
- Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Self-directed, resourceful, and able to get work done without significant input.
- Good organizational skills, attentive to details, and able to multitask.
- Strong problem-solving skills and ability to deal with changing priorities.
- Strong written, verbal, and presentation skills.
Preferred Skills:
- Prior experience in clinical research/ Investigator Sponsored Research, data management, or regulatory affairs, with at least two years of experience in the monitoring and management of clinical research projects is a plus
- Relevant Clinical Research experience and IST/EAP program management
Location Preference : Home Office ~ remote will be considered for the right candidate