Sr Project Mgr
Adecco Medical & Science is hiring a Sr Project Manager for our Pharmaceutical partner in Lawrenceville, NJ.The anticipated hourly wage for this position is between $58 and $61 Hourly wage may depend upon experience, education, geographic location, and other factors.Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, Daily Pay, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.Precision Medicine, CDx & Design Control ExecutionLead end to end program management for CLIA based diagnostic initiatives, including IUO assay design and development, analytical verification, assay transfer, and CLIA validation.Drive Design Control rigor across design inputs/outputs, risk management, traceability, design reviews, and Design History File (DHF) readiness in alignment with established TM QMS.Partner with Pathology/IHC, Molecular Diagnostics, Device Quality, Regulatory Affairs, and Lab Compliance to ensure compliant and timely clinical enablement.Integrate diagnostic strategies into clinical protocols to support patient stratification and early development decision making.Bioanalysis Program Management (GLP)Coordinate GLP compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies, including oversight of assay timelines, critical reagents, data transfers, and CRO deliverables.Ensure alignment of bioanalytical execution with IND enabling and clinical milestone expectations, in partnership with Regulatory and QA.Proactively manage interdependencies between diagnostics and bioanalysis where programs require coordinated execution.Provide program management for GLP quality execution, including inspection readiness, audit/inspection coordination, and CAPA governance in partnership with QA and study teams as neededQuality, Compliance & Data IntegrityOperationalize QMSR/21 CFR 820, GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11 requirements across laboratory operations, vendors, and data flows.Enforce Good Documentation Practices (GDP) and ALCOA/ALCOA+ principles across sample, method, and data lifecycles.Maintain inspection ready execution through disciplined documentation, validated systems (LIMS/EDMS), and audit ready records.External Partnerships & Vendor OversightServe as the primary program interface with CROs, CLIA laboratories, IVD/CDx partners, and specialty vendors.Define scopes of work, timelines, and deliverables; manage risks, issues, and escalations with a patient impact lens.Ensure vendors meet quality, compliance, and performance expectations.Program, Portfolio & Financial ManagementBuild and manage integrated project plans, risks, and dependencies across diagnostics and bioanalysis.Track timelines, forecast resources, and support budget visibility for program leadership.Provide concise, decision focused updates to stakeholders and leadership; escalate risks early with data backed mitigation options.Ways of Working & Culture• Model Behaviors: Urgency & Agility, Accountability, Innovation, Integrity, and Passion for Excellence.• Simplify interfaces, reduce operational friction, and apply data driven and AI enabled workflows where appropriate to accelerate execution.QualificationsRequiredBachelors degree in a scientific or engineering discipline; MS preferred.6+ years of experience in GxP regulated environments, spanning Precision Medicine / Diagnostics and/or Bioanalysis.Hands on experience with Design Control execution for IVD/CDx or IUO assays.Strong working knowledge of FDA QMSR (21 CFR 820), GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11.Proven ability to lead complex, cross functional programs in matrixed organizations.Pay Details: $58.00 to $61.00 per hourBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.Equal Opportunity Employer/Veterans/DisabledMilitary connected talent encouraged to applyTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacyThe Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance OrdinanceMassachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.