Clinical Trial Manager
Our Boston- based client is a leading clinical trials research organization with scientific leadership in translational and clinical studies using cardiovascular imaging in fields are looking to add a key management role to their team
Responsibilities of the Clinical Trial Manager include but are not limited to:
- Manage multi-center Phase I-IV or Pivotal as applicable clinical trials by site identification, protocol review with investigative sites, prequalification, initiation, clinical site management and study closeout.
- Oversight of clinical trial team including, Sr. Clinical Project Coordinators, Clinical Project Coordinators, and Clinical Trial Assistants (as applicable)
- Oversee study materials development and distribution, investigator meeting planning.
- Manage study start-up and clinical site management – escalation plan implementation.
- Manage central IRB submissions, and communications
- Reporting on Trial Timelines to Project Lead(s)
- Regulatory document collection oversight and internal approval (sign-off)
- Prepare or contribute to trial newsletters and communications
- Record, prepare and distribute meeting agendas and meeting minutes for team calls.
- Contribute to data review for governance calls with sponsor
- Contribute to authoring and review of project specific plans
- Contribute to review of statistical analysis plan, annual report, safety report and clinical study report review.
- Oversight of vendors e.g. clinical and specialty labs, technical vendors, core labs as applicable.
- Provide clinical assistance to sites, monitors, sponsor and other trial team members.
- Manage Medical Monitor documentation as applicable
- Other special projects as assigned by Senior Management including regulatory, safety or quality control oversight for a particular project or projects.
Skills / Requirements:
- Knowledge of FDA/GCP regulatory requirements
- Effective communication between site staff, sponsor, internal staff members
- Knowledge of Microsoft Office applications
- Ability to work on multiple activities concurrently
- Attention to detail and process
- 7+ years of clinical trial experience
- 3+ years of trial management experience
Education / Background:
- B.A. or B.S. degree in scientific field or equivalent
- Background in nursing in the cardiovascular therapeutic area or other clinical field is preferred.
If interested, please email Earl Callender email@example.com.