Clinical Trials Project Manager

RQMIS Inc. is a fast growing, medical device/biotechnology consultancy with a focus on regulatory strategy/submissions, clinical study design/management and quality systems design/compliance/auditing.

OVERALL RESPONSIBILITIES:

The Clinical Trials Project Manager will:

• Develop/implement/ manage all aspects of clinical trials in domestic and international countries for our clients.
• Provide training to clients and internal staff on such areas as clinical trial management, good clinical practices (GCPs), FDA Biomonitoring, CRF design, clinical report writing, Clinical Study Monitoring, etc.

POSITION DUTIES & RESPONSIBILITIES:

• Manage all aspects of clinical projects
• Provide training to clients and internal staff
• Write departmental procedures and assist in training efforts
• Participate in special projects as needed
• Travel required (up to 30 to 50%)
• Other duties as assigned

EDUCATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s degree in clinical/science field, or similar work experience
• 5 to 7 years experience in medical device clinical trials
• Previous supervisory or team leadership experience
• Knowledge of domestic/international medical device regulations
• Strong attention to detail
• Strong computer skills, including word processing, spreadsheet and data programs
• Good oral and written communication skills
• Good leadership skills
• Ability to manage several tasks simultaneously while continuously assessing company and/or departmental priorities

RQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.