Clinical Project Manager
3 weeks ago
**Job Summary**
**Clinical Project Manager - Hybrid In Office Position**
- Manage all aspects of multi-center Phase I-IV clinical trials
- Oversight and supervision of clinical operational trial team
- 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
- Regulatory document collection oversight and internal approval (sign-off)
- 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: $91,190.00 - $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 Clinical Research: 2 years (preferred)
Work Location: In person
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