CR ClinicalCEO | Clinical Project Manager | Independent Clinical Research Associate | Recruiter
Jun. 2015United StatesManage US and International multi-site trials (device and pharmaceutical). Responsible for overall project performance including timelines and budget, site selection/qualification, as needed. Act as the primary interface with sponsor on all aspects of the project. Develop Project Plans, Monitoring Plans, and Risk Management Plans. Train CRAs, Principal Investigators and Site Coordinators on study plans, clinical protocols and Good Clinical Practice. Directly manages project-related activities of field and in-house CRAs, assigned to the project team. Reviews and approves monitoring visit reports and takes action as required with Sponsor and/or sites. • Delegate clinical research task to monitors and other staff
• Oversee full clinical operations for clinical trial
• Manages a project as a project manager / project lead 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
• Identify study risks, issues, and deviations then develop trainings and CAPA plans