CLINICAL OUTCOMES MANAGER jobs in Newton, MA

Job Summary

Clinical Project Manager - Hybrid In Office Position

Cardiovascular Clinical Studies, a cardiovascular focused CRO (www.ccstrials.com), is looking for an exceptional Clinical Project Manager to join our fast-paced, quality focused, clinical team. Responsibilities include but are not limited to:

• 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
• Knowledge of Microsoft Office applications
• 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.

Job Type: Full-time

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