Assoc Project Manager

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use the newest technologies, and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD Laboratories, where science is our passion, quality is our commitment, and people are the cornerstone of our success.

As a Project Manager, you will manage all aspects of study programs while collaborating with diverse teams.

At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer career advancement opportunities, award-winning training, and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Monitors and manages all aspects of designated clinical trial protocols in Global Central Labs, accountable for overall project performance and client satisfaction by meeting their needs and expectations throughout the trial lifecycle. Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvements. Acts as chief liaison to operational personnel of major sponsors and manages large study programs. Prepares and maintains process documents and acts as a backup for the (Associate) Director PM when needed. Mentors Project Managers.

Essential Functions:

1. Provides oversight and coordination of study initiation. Reviews, interprets, translates, and programs study protocols into a complete and accurate database. Communicates with internal departments and external vendors to ensure project requirements are understood, agreed upon, and followed. Facilitates the flow of technical and clinical laboratory information to all stakeholders. Consults with laboratory management and technical staff to assist the client with trial management.
2. Prepares study specifications documents, ensuring they align with budgets and contracts. Maintains an updated study master file with version controls. Ensures sponsors have approved the most recent document versions and that contracts are in place before service delivery. Ensures compliance with FDA, GCP, PPD SOPs, personnel policies, and other relevant regulations regarding biological specimen transport.
3. During protocol review, consults with internal groups on procedural and budgetary items, addressing protocol amendments as needed. Serves as the main liaison between sponsor and internal departments, educating investigators through protocol-specific lab procedures during meetings. Manages daily activities during the trial to resolve issues and answer queries.
4. Collaborates with IT and data management teams in software design, validation, and implementation relevant to project management.
5. Works with Business Development and finance during project documentation review, supporting RFP assessments and drafting proposal responses.
6. Supports and mentors Project Managers and Setup Administrators, providing training and identifying areas for development. Authors and revises procedural documents. Acts as a backup for the (Associate) Director PM when necessary.

Job Qualifications

Education and Experience:

Bachelor's degree or equivalent, with relevant academic or vocational qualifications. Previous experience of 2+ years in a related role or an equivalent combination of education, training, and experience.

Knowledge, Skills, and Abilities:

• Strong verbal, written, and presentation skills
• Excellent time management, planning, and organizational skills
• Proficiency in programming IT systems according to protocol requirements
• Proven analytical skills
• Adherence to procedures and policies