What are the responsibilities and job description for the Clinical Project Manager position at Insight Global?
JOB DESCRIPTION
Insight Global is looking for Clinical Project Managers to service one of our largest CRO Clients - sitting completely Remote.
Duties Include:
Documentation and Reporting:
Business Development:
Management:
Duties Include:
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
- 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 and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Accountable for all project deliverables for each project assigned.
Documentation and Reporting:
- 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.
- Plan, coordinate and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
Business Development:
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- May participate in bid defense meetings where presented as potential project manager.
Management:
- May be required to line manage other project management team members and clinical monitoring staff.
MINIMUM REQUIREMENTS
- At least 3 years of Full Scope Clinical PM Experience coming from a (Pharma or CRO) background .
- Experience running a trial from start to finish.
- Any type Therapeutic experience preferably Oncology based
- Experience holding and monitoring trial budgets
- Experience running trials from Start-up, maintenance, to close out
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