Clinical Project Manager
Core
End-to-end management of clinical trials ensuring alignment with Sponsor expectations, delivering studies on time, within budget, and in compliance with regulations.
Role type
Senior Clinical Project Manager
Builds
Clinical trials and study deliverables
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial lifecycle management, budget management, vendor coordination, stakeholder management, regulatory compliance (GCP, ISO, MDD/MDR), audit and inspection management, Serious Adverse Event handling, study documentation management, training delivery
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and manage assigned team members to achieve organizational goals; Oversee full lifecycle of clinical projects including planning, timelines, and budget management; Coordinate all clinical services (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) throughout the study lifecycle; Act as primary point of contact for stakeholders on feasibility, study design, and progress reporting; Lead periodic Sponsor meetings and finalize minutes; Manage Sponsor-provided study documentation and coordinate preparation of core documents for regulatory submissions; Prepare and maintain Study Manuals, Trial Master File (TMF), and Investigator Study File (ISF); Oversee monitoring activities ensuring timely delivery of reports; Deliver study-specific training to internal teams and site staff; Manage audit and inspection findings and implement corrective actions; Ensure proper handling of Serious Adverse Events (SAEs); Report protocol and GCP violations to Quality Assurance.
Seniority
Senior, hands-on IC
