Manages a project as a project manager overseeing interdisciplinary clinical research studies.
Ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
Acts as a primary liaison between the Company and the Customer.
Lead project team to ensure quality, timelines and budget management.
Accountable for the financial performance of each project.
Coordinate activities and deliverables of all study conduct partners.
Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
Responsible for quality and completeness of TMF for assigned projects.
Accountable for maintenance of study information on a variety of databases and systems.
Responsible for study management components of inspection readiness for all aspects of the study conduct.
Oversight for development and implementation of project plans.
Prepare project management reports for clients and management.
Developing contingency planning and risk mitigation strategies.

Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
Clinical research organization (CRO) and relevant therapeutic experience preferred.
Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Strong organizational skills.
Strong ability to manage time and work independently.
Direct therapeutic area expertise.
Ability to embrace new technologies.
Excellent communication, presentation, interpersonal skills, both written and spoken.
Ability to travel as necessary (approximately 25%).

company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time

Study Manager – Future Roles

Key skills