Clinical Supply Project Manager

JOB DESCRIPTION

Position: Clinical Supply Project Manager

Department: Project Management

Reports To: Director, Project Management

Location: Cranbury, NJ

Classification: Full time

FLSA Status: Exempt

Under minimal supervision, the incumbent is responsible for the project management of assigned clients including but not limited to the planning of project resources, assembling, or leading the project team, time management, budget, scope, quality and satisfaction, risk management, monitoring progress, documentation, and reporting.

• Management of project related activities from definition to launch stage to ensure that projects are delivered on-time, within approved budget and achieves project objectives.
• Organize and lead project core team meetings.
• Maintains effective communication and working relationships among project core team.
• Ability to translate clinical trial synopsis / clinical trial protocol into an efficient and cost-effective plan including, but not limited to:
• Material Management
• Manufacturing, Packaging & Labeling - Prepare documents such as, but not limited to, material specifications and batch records.
• Prepare required distribution documentation, enter & monitor shipments.
• Prepare required Returns, Accountability and Destruction documentation.
• Manage all project related inventory to avoid stock out scenarios.
• Work with cross-functional team members to assess feasibility of project scope and objectives and develop detailed project timeline to ensure that there is enough flexibility and contingency in the plan to respond to unanticipated difficulties.
• Define and assign schedules and track cross-functional tasks/activities to ensure that project progress within expected timings.
• Management of monthly project invoicing.
• Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution.
• Interface with all functional areas of the business to ensure timely, effective, and efficient execution of project tasks.
• Lead risk analysis & mitigation planning for projects.
• Prepare and present project progress reports and presentations as required.
• Carries out duties in compliance with all federal and state regulations and guidelines.
• Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
• Remains current in profession and industry trends.
• Makes a positive contribution as demonstrated by:
• making suggestions for improvement
• learning new skills, procedures, and processes.
• Is available for other duties as required.

• Bachelor’s Degree preferred.
• At least five (5) years of project management experience in packaging, labeling and clinical supply chain as Project Manager.
• Commercial packaging experience a plus.

• Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
• Legible Handwriting
• Communicate clearly in writing and orally.
• Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4, and Annex 13.
• Demonstrate effective collaboration and teamwork.
• Demonstrate experience managing contract pharmaceutical projects on time and on budget.
• Demonstrate experience working in a cGxP environment.
• Familiar with project management tools and technologies such as Microsoft Project.
• Knowledge of various project management methodologies.
• Successfully completes regulatory and job training requirements.
• Computer skills:
• Enter data into computer using software applications for data entry and word processing.
• Work and be proficient with e-mail systems.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Ability to work with others in a team environment.

In Office Role: 4 days in office in Cranbury, NJ office, 1-day WFH.

$100,000 to $125,000

Standard office environment

Office Environment (standing and sitting) requiring minimal physical exertion.

Domestic travel will be required less than 5% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential…