Project Manager

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Direct and manage central laboratory operations across various clinical trial programs.

• Oversee and handle specified clinical trial protocols within Global Central Labs.

• Ensure optimal project performance and client satisfaction throughout the duration of assigned trials.

• Provide internal consultancy on project management challenges and identify opportunities for process and efficiency enhancements.

• Serve as the primary contact for sponsors, operational staff, internal teams, external vendors, and stakeholders.

• Supervise and coordinate the initiation of studies.

• Analyze, interpret, and convert study protocols into comprehensive and precise databases.

• Facilitate the flow of technical and clinical laboratory information to relevant stakeholders.

• Draft study specification documents in accordance with budgets and contracts.

• Keep updated study master files with version control.

• Ensure sponsor approval, document sign-off, and contract finalization prior to service delivery.

• Maintain compliance with FDA regulations, Good Clinical Practice, PPD SOPs, IATA, and biological specimen transport standards.

• Coordinate reviews for protocol amendments and secure cross-functional commitment to address gaps and issues.

• Educate investigator sites through presentations and demonstrations of protocol-specific laboratory procedures.

• Manage daily clinical trial operations, address issues, and respond to inquiries.

• Collaborate with IT and data management teams on the design, validation, and implementation of software and functionalities.

• Assist in RFP feasibility assessments and draft responses to proposals.

• Guide, train, and mentor Project Managers and Set-up Administrators.

• Write, review, revise, and implement procedural documents.

• Act as a backup for the Associate Director of Project Management when necessary.

⛳️ Requirements

• Bachelor’s degree or an equivalent and relevant formal academic or vocational qualification.

• Prior experience providing the necessary knowledge, skills, and abilities to perform the role, typically 2+ years, or a comparable combination of education, training, and experience.

• Excellent verbal, written, and presentation skills.

• Exceptional time management, planning, and organizational capabilities.

• Proficient with computers and enterprise software, including office productivity tools.

• Capability to program the IT system in line with protocol specifications.

• Strong analytical abilities.

• Proven adherence to procedures and policies.

• Ability to effectively manage multiple tasks in a high-pressure environment.

• Extensive knowledge and experience in project management within a Global Central Lab setting.

• Strong skills in client relationship management.

• Ability to collaborate effectively with teams at various levels.

• Capacity to communicate, receive, and comprehend information and ideas with diverse groups.

• Ability to remain upright and stationary during typical work hours.

• Proficient in the use and learning of standard office equipment and technology.

• Ability to perform effectively under pressure while prioritizing and managing multiple projects or activities.

• May require travel.

• Must be legally authorized to work in the United States without sponsorship.

• Must successfully pass a comprehensive background check, including drug screening.

🏝️ Benefits

• Fully remote work arrangement.

• Opportunity to collaborate with industry-leading experts.

• Contribution to groundbreaking clinical research.

• Career advancement within a culture that values innovation, accountability, and ongoing development.

• Reasonable accommodations for applicants with disabilities.

• Equal employment opportunities and accessibility support.