Senior Clinical Project Manager
We are looking for a motivated and team-oriented individual who will be a key contributor to the overall success of Aileron’s clinical development program. In this newly created role, the Clinical Project Manager will be responsible project management for clinical trials.
- Manage all aspects of assigned clinical trials in accordance with FDA, GCP, and ICH guidelines. Create and oversee project timelines and budgets.
- Contribute to the creation and review of essential trial documents such as protocols, informed consents, case report forms, and study manuals.
- Evaluate, select, negotiate, contract and manage service providers (e.g. CROs, lab vendors). Develop and execute quality management plan.
- Maintain trial level tracking, including enrollment, trial status, and SAE reporting.
- Ensure trial delivery on time, on budget and with appropriate quality. Identify potential risks to budget and timeline.
- Establish relationships with site personnel; lead investigator calls.
- Manage study supplies and study drug ordering.
- Oversee maintenance of the trial master file.
- Review clinical data; work with programming team and medical on publications.
- Travel to sites to oversee CRAs and assist sites with trial execution.
- Coordinate with finance department for site payments.
- Create SOP’s and templates as needed.
Qualifications and Experience
- Bachelor degree; BS in health/scientific related field preferred
- Minimum of 5 years experience in clinical research in CRO, pharmaceutical or biotechnology environment
- Forecasting and budgeting experience
- Deep knowledge of regulatory guidelines including ICH/GCP
- Strong attention to details and solid follow through.
- Strong communication and organizational skills
- Strong technology skills (e.g. Microsoft Excel, Word, Project, PowerPoint)
Aileron has an engaging culture of innovation and team work and we are continuing to build a top-tier team to rapidly advance our programs in a fast-paced, collaborative work environment. We offer a robust benefits package including premium health/dental plans with industry leading company contribution, 401(k) retirement plan, incentive stock options, 3 weeks vacation, frequent catered lunches, and professional and career development.