Home-Based Clinical Project Manager/Senior Clinical Project Manager (General Medicine)

Provides customer-focused leadership in managing clinical projects across various phases, functional areas and assigned clinical staff

Accountable for the successful execution of all assigned projects, where success includes on-time, on-budget, high-quality/compliant project results that lead to satisfied customers

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

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

Develops strong relationships with current clients to generate new and/or add-on business for the future

Must Haves:

• 4 year degree is
• Recent CRO Clinical Project Management experience

PM: 3+ years of full scope Clinical Project Management experience independently managing trials (from start up to close out) including budgets, cross-functional teams, risk mitigation, timelines/deliverables, etc.

Senior PM: 5+ years of full scope Clinical Project Management experience independently managing trials (from start up to close out) including budgets, cross-functional teams, risk mitigation, timelines/deliverables, etc., and 3+ years of Global CPM experience

Direct Dermatology, Vaccines, Infectious Disease or Anti-Bacterials PM experience