Project Manager - Labs

Work is performed in a laboratory and/or clinical environment with exposure to electrical office equipment. Occasional drives to site locations and occasional domestic travel. Exposure to biological fluids with potential exposure to infectious organisms, rare exposure to skin and lung irritants, radiation, toxic materials, and hazardous waste. Personal protective equipment required such as protective eyewear, garments, and gloves. Rare exposure to fluctuating and/or extreme temperatures.

About the role

The Senior Project Manager - Labs leads and has direct oversight for a portfolio of projects for a specific client and is accountable for overall project/portfolio performance. Proactively identifies resources, budgets projects, prioritizes the client's portfolio in line with the site-wide portfolio of projects, and is the primary operational interface between PPD and the client. Negotiates and makes real-time decisions with the client. Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.

This position is part of the Sample and Data Management group. Personnel are responsible for the review and approval of data within LIMS, issuing Certificate of Analysis (CoA) and Detailed Sample Reports (DSRs), communicating timelines internally and externally, and facilitating other documentation as needed for the entire Clinical Biologics network, as well as assisting in other GLP/GMP compliance activities as assigned.

Responsibilities

• Manages project and program timelines, prioritizing LIMS data review and approval based on business needs, production dates, and filing requirements. This is a fast-paced, high-volume role that requires efficient decision-making and the ability to adjust quickly to changing priorities across the Clinical Biologics network.
• Reviews and approves data within LIMS to ensure data packages are complete, accurate, and available to support timely Certificate of Analysis (CoA), Detailed Sample Report (DSR), and regulatory filing needs.
• Communicates internally and externally with analytical leads, contract laboratories, ATLs, analysts, managers, and personnel at other BMS sites to ensure data review and approval activities are completed in a timely manner.
• Works closely with contract laboratories and analytical leads to track deliverables, communicate delays or issues that arise, and drive appropriate follow-up to support project and program timelines.
• Troubleshoots LIMS issues identified during data review and approval, coordinating with appropriate stakeholders to resolve discrepancies, system questions, or process barriers.
• Responsible for the issuance of various document types (e.g., CoA, DSR) and acts as project manager to ensure program timelines are met.
• Independently creates, revises, formats, routes, distributes, maintains, and stores departmental documents consistent with GMPs as needed.
• Trains department personnel and colleagues on documentation practices and templates as needed.
• Cross-trains in facilitation of Justification of Specifications, PD LIMS Specification creations/revisions routinely and as needed based on volumes.
• Authors and revises department SOPs, as applicable.
• Ensures quality while processing a high volume of methods and technical documents.
• Provides back-up support to manager and team members in support of other documents as needed.
• Provides expertise and troubleshooting for Microsoft Word and Excel, Adobe Acrobat Pro, and EDMS systems.

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 5+ years) or equivalent combination of education, training, and experience. Project management experience preferred.
• Proficient in use of electronic systems: Microsoft Office Suite, DCA (Document Control and Archiving), Documentum, RMS (Records Management System), Adobe Acrobat, PDLIMS, and Internet Research.
• Understands scientific concepts in order to conduct thorough review of documentation and data.
• Knowledge of cGMP requirements.
• 5-10 years of GMP Documentation experience or bachelor’s degree and/or technical degree.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

Pay

The salary range estimated for this position based in New Jersey is $95,000.00–$115,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.