Dexian It Solutions
From Dexian It Solutions's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Job Title: Clinical Supply Project Manager
Employment Type: Contract
Duration: 12+ Months
Work Arrangement: Hybrid - 50% onsite
Work Schedule: Monday-Friday, Normal Business Hours
Position Summary
We are seeking an experienced Clinical Supply Project Manager to support the planning, coordination, and execution of clinical supply projects within a pharmaceutical environment. This individual will manage multiple projects, coordinate clinical packaging and labeling activities, oversee production schedules, and ensure timely delivery of finished clinical supplies.
The ideal candidate will have experience in pharmaceutical operations, clinical trial supply management, SAP, and GMP-regulated environments, along with strong project management and cross-functional coordination skills.
Manage multiple clinical supply projects, ensuring activities and deliverables are completed within established timelines.
Develop and maintain detailed project schedules, track milestones, and monitor production activities to ensure on-time delivery.
Coordinate clinical trial packaging and labeling requirements with internal stakeholders.
Ensure availability of required materials, drug products, packaging components, randomization files, and label text.
Create and manage Bills of Materials (BOMs) and production/process orders in SAP.
Execute SAP transactions, including goods receipt, goods consumption, and production order management.
Review BOM structures, production specifications, and process orders for accuracy and compliance.
Compile batch records and supporting documentation required for the release of finished clinical supplies.
Collaborate with Quality Assurance teams to facilitate the release of finished products for clinical use.
Review vendor-generated label proofs, production orders, specifications, and change-related documentation.
Ensure activities comply with applicable regulatory requirements and GMP/CGMP standards.
Support deviation reporting, change controls, and quality investigations as assigned.
Collaborate with cross-functional teams, vendors, and stakeholders to resolve project-related challenges.
Identify opportunities for process improvements and contribute to continuous improvement initiatives.
Author, review, and maintain procedural documentation and participate in required compliance and safety training.
Required Qualifications
Bachelor's degree in Pharmacy, Engineering, Business, Life Sciences, or a related discipline.
5-7 years of relevant experience in the pharmaceutical industry or a related healthcare environment.
Experience managing multiple projects and coordinating critical deliverables.
Knowledge of pharmaceutical supply chain, production planning, and ERP/MRP systems.
Hands-on experience with SAP, including BOMs, production orders, and related transactions.
Strong organizational, communication, and project management skills.
Ability to manage competing priorities and meet deadlines in a fast-paced environment.
Strong problem-solving and decision-making abilities.
Background in clinical packaging and labeling.
Knowledge of GMP/CGMP regulations and pharmaceutical quality systems.
Experience with batch documentation, QA release processes, deviations, and change controls.
Experience coordinating with external vendors and cross-functional pharmaceutical teams.
Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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