Labs Project Manager

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

📋 Description

• Lead and manage central laboratory operations across clinical trial programs.

• Oversee and monitor all elements of assigned clinical trial protocols in Global Central Labs.

• Supervise study initiation and ensure accurate translation of protocols into comprehensive databases.

• Collaborate with internal teams and external vendors to guarantee project requirements are clearly understood and adhered to.

• Facilitate the flow of technical and clinical laboratory information between investigational sites, sponsors, and non-technical staff.

• Create study specification documents and maintain master files with version control for specifications, budgets, and contracts.

• Ensure sponsor approval and sign-off on current documents and validate contracts prior to service delivery.

• Maintain compliance with FDA regulations, Good Clinical Practice, PPD Standard Operating Procedures, personnel policies, exposure-control requirements, IATA, and biological specimen transport regulations.

• Coordinate reviews of protocols, amendments, budgets, and resolve issues across internal departments.

• Act as the primary liaison between sponsors and PPD internal teams throughout all study phases.

• Provide education to investigator sites through presentations and demonstrations of protocol-specific laboratory procedures.

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

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

• Assist with RFP feasibility assessments and prepare proposal responses alongside business development and finance teams.

• Mentor, guide, and train Project Managers and Set-up Administrators.

• Identify workflow efficiencies and author, review, update, and implement procedural documentation.

• Serve as a backup for the Associate Director PM as necessary.

⛳️ Requirements

• Bachelor’s degree or equivalent with relevant formal academic or vocational qualifications.

• A minimum of 2 years of prior experience, or a comparable combination of education, training, and experience.

• Excellent verbal, written, and presentation communication skills.

• Exceptional time management, planning, and organizational abilities.

• Proficiency with computers and enterprise applications, including office productivity software.

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

• Proven analytical capabilities.

• Demonstrated 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 context.

• Strong skills in client relationship management.

• Capacity to work efficiently with multi-level teams.

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

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

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

• Capability to remain upright and stationary for standard working hours.

• Ability to proficiently use and learn standard office equipment and technology.

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

• Travel may be required.

🏝️ Benefits

• Global organization dedicated to employee health and wellbeing.

• Healthy and balanced work atmosphere.

• Opportunities for continuous development and growth.

• Accessibility services and accommodations available for job seekers with disabilities.