The Learning Corp (TLC) is a fast-growing, next-generation digital therapeutics company that is improving the effectiveness of brain rehabilitation technology through the use of Artificial Intelligence (AI). Our award-winning mobile app, Constant Therapy, features clinically proven exercises for people with brain injury, and cognitive or speech disorders. We are seeking outstanding people that are driven by a desire to make an impact.
TLC has an immediate opening for a Clinical Program Manager to lead the delivery of scientific studies such as randomized controlled clinical trials, outcomes studies, and other research initiatives. This position will work very closely with internal business teams and may involve the management of external stakeholders such as CROs. The position is based out of our Newton, MA office.
Responsibilities include, but are not limited to:
- Manage one or more clinical programs, including outcomes studies, randomized trials, pilot evaluations
- Contribute to clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, and trial reports
- Manage our CRO relationships. Review and approve study-related plans generated by CROs, and ensure that the documentation is in accordance with regulatory requirements
- Anticipate, recognize and resolve issues; including the escalation of study related questions with management and other R&D functions
- Ensure audit-readiness of clinical trial documentation, including the trial master file
- Review monitoring reports to ensure the quality and resolution of site-related issues
- A bachelor’s degree, ideally in a scientific/healthcare-related field
- Experience in clinical development, ideally within the pharmaceutical/biotech space, with some expertise in clinical trials management and a thorough knowledge of FDA and ICH GCP guidelines
- Experience managing protocols, CROs, budgets, and timelines
- Outstanding professional communications skills including authoring of clinical documentation and communications with investigators, CROs, senior leadership, etc.
- Superlative problem-solving skills, excellent detail-orientation and the ability to think ahead and anticipate needs
- An ability to define, disambiguate and prioritize project objectives
- A deep commitment to high-quality output with an appropriate level of focus on details
Nice to have:
- Masters-level degree (MS, MPH, or MBA)
- PMP certification
- Experience in virtual trials or “non -traditional” trial designs is preferred