Project Manager, Central Labs

Role Responsibilities

• Provide oversight and coordination of study initiation.
• Review, interpret, translate and program study protocols into a complete and accurate database.
• Communicate with internal departments and external vendors to ensure project requirements are understood, agreed upon, and followed at all times.
• Facilitate the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel).
• Consult and utilize, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial.
• Prepare study specification documents and follow their preparation according to budgets and contracts.
• Maintain at all times an updated study master file with version controls for specifications, budgets, and contracts.
• Ensure sponsors have authorized and signed off on the most recent versions of all documents and that a contract exists prior to delivering any services.
• Assure compliance with FDA and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens.
• During the initial review of the protocol, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for changes due to any subsequent protocol amendments.
• Obtain other functions' commitment to close gaps and address issues timely and effectively.
• Serve as chief liaison between the sponsor and all PPD internal departments performing the required tasks during all study phases.
• Educate Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during an investigator meeting.
• Control, manage, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queries.
• Actively consult with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities.
• Consult with BD and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments.
• Advise on possible solutions if needed.
• Draft responses for proposals.
• Guide and support workflow of Project Managers and Set-up Administrators with special attention to training junior personnel, perform as a mentor and trainer for (newly assigned) Project Managers, identify areas for development and efficiencies in performing tasks, author, review, revise and implement relevant procedural documents, and serve as a backup for the Associate Director PM when needed.

Key Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience.

Knowledge, Skills, Abilities

• Strong verbal, written and presentation skills
• Superior time management, planning, and organizational skills
• Competent with specific computers and enterprise applications, including office productivity
• Ability to program the IT system according to protocol requirements
• Proven analytical skills
• Demonstrated compliance with procedures and policies
• Ability to perform multiple tasks effectively in a stressful environment
• Extensive knowledge and experience in Project Management in Global Central Lab environment
• Strong client relationship management skills
• Ability to work effectively with multi-level teams