Project Manager - Clinical Supply
SOKOL GxP Services New Brunswick, New Jersey, United States · $92K–$116K/yr
Pharmaceutical Manufacturing · 11-50 employees
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About the role
The Project Manager will coordinate clinical trial packaging and labeling projects within a GMP-regulated environment. Responsibilities include managing project schedules, executing SAP transactions, and collaborating with Quality Assurance to ensure regulatory compliance.
What they look for
Requirements
Candidates must hold a bachelor's degree in a relevant field and possess at least 3 years of experience in a GMP-regulated environment. Proficiency in SAP and clinical trial supply operations is required, along with the legal authorization to work in the United States.
Benefits
Full description
We are seeking a Clinical Supply Project Manager to coordinate clinical trial packaging and labeling projects in a GMP-regulated pharmaceutical environment. This position focuses on clinical supply delivery, SAP production orders, material coordination, and cross-functional project execution.
Key responsibilities:
- Manage multiple clinical supply packaging and labeling projects, tracking schedules, milestones, and delivery commitments.
- Coordinate drug products, packaging components, label text, randomization files, and other project deliverables.
- Create and release Bills of Materials (BOMs) and production/process orders in SAP.
- Execute SAP transactions, including goods receipt, goods consumption, and technical completion (TECO).
- Review packaging and labeling specifications, vendor label proofs, production orders, and change orders.
- Coordinate with Quality Assurance to support batch record documentation and release of finished clinical supplies.
- Maintain cGMP and regulatory compliance, support deviation and change control activities, and contribute to process improvements.
- Author and review procedural documentation.
Position details:
- Hourly rate: $44.04–$55.94;
- Contract length: 12 months with possible extension;
- Location: New Brunswick, NJ;
- Work arrangement: Hybrid, 50% onsite;
- Schedule: Monday–Friday, normal business hours;
- Maximum hours: 40 hours per week;
- W-2 contract position;
- No C2C options;
- No visa sponsorship.
Required:
- Bachelor's degree or equivalent in pharmacy, engineering, business, or life sciences;
- At least 3 years of experience in a GMP-regulated environment;
- At least 3 years of clinical trial or packaging/labeling experience;
- At least 3 years of Microsoft Office 365 experience;
- Experience with ERP systems, such as SAP;
- Strong project management skills, including managing multiple projects and critical timelines;
- Strong written and verbal communication, decision-making, and organizational skills;
- Knowledge of ERP/MRP systems and supply chain principles;
- Authorization to work in the United States without visa sponsorship.
Preferred:
- 5–7 years of relevant pharmaceutical industry or related healthcare experience;
- Clinical supply or clinical trial experience;
- Experience with clinical packaging and labeling operations;
- Experience with SAP Bills of Materials, process orders, and related transactions;
- Ability to communicate effectively across teams and influence project outcomes.
- Health insurance with dental and vision insurance options.
- Holiday pay.
- 401(k) program.
- Employee referral bonus program.
- The client retains the right to hire the contractor directly.
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