What are the responsibilities and job description for the Senior Project Manager position at Careers Integrated Resources Inc?
Job Title: Senior Project Manager
Location: Lawrenceville, NJ
Duration: 10 Months
Description: Precision Medicine, CDx & Design Control Execution
•Lead 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 needed
Quality, Compliance & Data Integrity
•Operationalize 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 Oversight
•Serve as the primary program interface with CROs, CLIA laboratories, IVD/CDx partners, and specialty vendors.
•Define Products 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 Management
•Build 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.
Qualifications
Required
•Bachelor’s 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.
Location: Lawrenceville, NJ
Duration: 10 Months
Description: Precision Medicine, CDx & Design Control Execution
•Lead 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 needed
Quality, Compliance & Data Integrity
•Operationalize 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 Oversight
•Serve as the primary program interface with CROs, CLIA laboratories, IVD/CDx partners, and specialty vendors.
•Define Products 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 Management
•Build 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.
Qualifications
Required
•Bachelor’s 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.