Project coordinator

Job Title: Project Manager – Clinical Supply

Location: New Brunswick, NJ (50% onsite)

Duration: 12 Months (Potential Extension)

Pay Rate: $45–$55/hr on W2

Work Schedule: Monday–Friday, Normal Business Hours

Job Description:

We are seeking an experienced Project Manager to support clinical supply operations within a pharmaceutical environment. The ideal candidate will have experience managing clinical supply projects, GMP compliance, SAP-based packaging and labeling operations, and cross-functional coordination.

Key Responsibilities:

• Manage multiple clinical supply projects and ensure timely delivery of clinical supplies.
• Coordinate with Trial Supply teams on clinical packaging, labeling requirements, study specifications, and production schedules.
• Develop project timelines, track milestones, and coordinate deliverables, including drug products, packaging components, randomization files, and label text.
• Create and release Bills of Materials (BOMs) and process orders in SAP.
• Execute SAP transactions, including goods receipt, goods consumption, order conversion, and technical completion (TECO).
• Ensure BOMs align with packaging specifications and clinical trial requirements.
• Compile batch records and coordinate with Quality Assurance for clinical supply release.
• Review vendor label proofs, order specifications, production orders, and change documentation.
• Ensure compliance with GMP and regulatory requirements while supporting deviations, change controls, and investigations.
• Collaborate with cross-functional teams and support continuous improvement initiatives.

Required Qualifications:

• Bachelor's degree in Pharmacy, Engineering, Business, Life Sciences, or a related field.
• 5–7 years of relevant experience in the pharmaceutical or healthcare industry.
• Minimum 3 years of experience in a GMP-regulated environment.
• Minimum 3 years of clinical trial operations or pharmaceutical packaging/labeling experience.
• Hands-on experience with ERP systems, preferably SAP.
• Strong understanding of supply chain processes and project management principles.
• Minimum 3 years of experience with Microsoft Office 365.
• Excellent written and verbal communication, organizational, and coordination skills.

Preferred Qualifications:

• Experience in clinical packaging and labeling operations.
• Experience with SAP Bills of Materials (BOMs) and process orders.
• Experience with batch records, SOPs, and GMP documentation.
• Experience coordinating with vendors and Quality Assurance teams.

About TSR Consulting:

TSR Consulting is a trusted staffing and workforce solutions partner with more than 50 years of experience delivering highly qualified talent to support clients' most critical business and technology initiatives. TSR was acquired by BCforward, a leading global IT consulting and workforce solutions firm founded in 1998 by Justin Christian, in June 2024.