Project Manager - Operations (Pharma)

Clinigen•Malvern, PA

7h•Hybrid

About The Position

The Project Manager, Operations is responsible for the overall direction, coordination, implementation, execution, and completion of assigned client projects. The role ensures consistency with company strategy, commitments, and goals for providing quality service in accordance with the highest cGMP standards. This is a hybrid role requiring three days in the office, and the successful candidate must live within commuting distance of Malvern, Pennsylvania, USA. Domestic travel to clients may be necessary and will be evaluated case by case.

Requirements

Bachelor’s degree and/or equivalent work experience relative to knowledge of cGMP principles and practices and Clinical Trial Management.
Experience with project management phases, techniques, and tools.
Flexible and adaptable to changing situations.
Detailed and proactive approach to managing and solving daily operational problems.
Excellent interpersonal communication and listening skills.
Superior time-management skills in a fast-paced environment.
Ability to critically evaluate situations and adapt quickly when making timely, independent decisions.
High level of initiative and ability to work well independently and as a team member.

Responsibilities

Create and maintain project timelines based on client needs.
Coordinate, manage, and review client-specific project details, including packaging, labeling, dispensing, and distribution of clinical trial materials and ancillary supplies, with close attention to accuracy.
Review and approve packaging, distribution, and return documents.
Review and monitor inventory thresholds and expiry dating.
Assist in sourcing materials as outlined in client-specific documentation.
Provide distribution solutions for cold-chain supplies and controlled-temperature shipments.
Use project management tools to plan and evaluate projects and submit risk-assessment timelines.
Perform drug reconciliation, generate accountability and reconciliation reports, and submit project close-out reports.
Act as a liaison between clients and Clinigen CSM.
Partner with Operations team members to track outstanding requests and improve the inventory database.