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Clinical Trial Project Manager

1 month ago

Étreux, Hauts-de-France, United States Brigham & Women's Hospital(BWH) Full time
Job Summary

We are seeking a highly skilled Clinical Trial Project Manager to oversee study recruitment and retention activities for federal and industry-sponsored clinical trials in men's health. The successful candidate will work closely with study PIs and research team members to develop and implement study-specific recruitment strategies, maximize the utilization of existing recruitment methods, and pioneer new and innovative methods to enhance overall recruitment efforts and enrollment efficiency.

Key Responsibilities
  • Develop and lead the implementation of clinical trial recruitment strategies and social media postings for single-site and multi-site clinical trials.
  • Prepare summary reports for project teams regarding enrollment status and study progress.
  • Oversee the preparation of study-specific recruitment materials for IRB submission.
  • Contribute to the development of study-specific documents, e.g., case report forms (CRFs), eligibility screening script and questionnaires, and subject recruitment materials.
  • Identify protocol challenges and opportunities for recruitment/retention.
  • Initiate discussions to promote effective use of the recruitment and retention tools available to the site/study.
  • Prompt site follow-up on pre-identified participants/screen failed patients.
  • Construct and maintain study database as well as oversee data entry on an ongoing basis.
  • Assure adherence to intended timelines and achievement of study goals.
  • Develop and implement measures to improve efficiency in recruitment operations.
  • Direct management responsibility for study personnel, including 2 senior research coordinators, 2 research assistants, up to 5 undergraduate/graduate student assistants, student interns, and per diem staff.
Requirements
  • Master's degree.
  • Minimum of 3-5 years of progressively more responsibility clinical research recruitment experience.
  • Minimum of 3 years prior experience management responsibility of research staff required.
  • Proven record of successful problem-solving and decision-framing skills pertaining to clinical trial recruitment.
  • Proficiency in Microsoft Office applications (e.g., Outlook, Word, and Excel).
  • Familiarity with electronic data capture (EDC) systems preferred (e.g., REDCap).
  • Intermediate knowledge of medical terminology preferred.
  • Certifications in the Protection of Human Subjects and Good Clinical Practice, per institutional and regulatory guidelines.
Competencies
  • Excellent organizational skills and an ability to effectively manage research personnel, time, and prioritize workload.
  • Strong oral and written communication skills.
  • Excellent critical thinking and problem-solving skills.
  • Analytical skills necessary to accurately interpret and implement complex policy.
  • Comfortable working both independently and as part of a team.
  • Excellent interpersonal and relationships skills. Ability to build rapport and interact effectively with a broad array of people from diverse cultural and educational backgrounds.
  • High degree of professionalism, discretion, and confidentiality.
  • Ability to supervise and train staff effectively.
  • Strong database management, analytical, and computer skills.