Clinical Project Manager - Boston, United States - Cardiovascular Clinical Studies
1 week ago
Description
Job Summary
Clinical Project Manager - Hybrid In Office Position
- Manage all aspects of multicenter Phase I-IV clinical trials
- Oversight and supervision of clinical operational trial team
- Oversee study materials development and distribution, investigator meeting planning
- Manage study startup and clinical site management escalation plan implementation
- Manage central IRB submissions, and communications
- Regulatory document collection oversight and internal approval (signoff)
- Prepare Monthly Trial newsletters
Record, prepare and distribute meeting agendas and meeting minutes for team calls:
- Executive Committee Management (set up, charter drafting, coordination of meetings, meeting minutes, master files, etc)
- Oversight of vendors e.g. clinical and specialty labs, technical vendors, core labs
- Provide clinical assistance to sites, monitors, sponsor and other trial team members
- 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
- Ability to work on multiple activities concurrently
- Attention to detail and process
Work Experience
- 7+ years of clinical trial experience
3+ years of Project Manager Experience Required
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.
Pay:
$91, $121,190.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Application Question(s):
- How many years experience do you have working in Clinical Research either at a CRO or Site?
- This is NOT a remote position, Will you be able to come into the office 5 days a week located in Boston, MA
Experience:
- Project management in
Work Location:
In person
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