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.

Responsibilities

  • 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.
 

Please forward your CV/resume to Careers@aileronrx.com
Aileron Therapeutics, Inc. 281 Albany Street, Cambridge, MA 02139
www.aileronrx.com

Brenda Duane