Project Manager - Operations (Pharma)

Clinigen•Malvern, PA

11h•Hybrid

About The Position

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. The Project Manager, Operations is responsible for the overall direction, coordination, implementation, execution, and completion of assigned client projects while ensuring consistency with regards to company strategy, commitments, and goals of providing quality and service in the highest cGMP Standards. This will be a hybrid role with 3 days in the office. The successful candidate must be within a commutable distance to Malvern, PA, USA.

Requirements

Bachelor’s degree and/or equivalent work experience relative to the knowledge of principles and practices involved in cGMP and Clinical Trial Management
Experience in the phases, techniques, and tools of project management
Flexible and adaptable to changing situations
Possess a detailed and proactive approach to management in problem solving of daily operations
Excellent interpersonal communication and listening skills
Superior time management skills for working within a fast-paced environment
Able to critically evaluate situations, and adapt quickly in making timely and independent decisions
Must demonstrate a high level of initiative and the ability to work well independently and as a team member

Responsibilities

Create and maintain a project timeline based on client needs
Coordinate, manage and review all client specific project details including the packaging, labeling, dispensing, and distribution of clinical trial material and ancillary supplies with maximum attention to accuracy
Review and approve packaging, distribution, and return documents.
Review and monitor inventory thresholds and expiry dating
Assist in sourcing material as outlined in client specific documentation.
Provides distribution solutions for cold chain supplies and controlled temperature shipment needs
Utilize project management tools to ensure time management in adequate planning, evaluation, and submission of risk assessment timelines on projects
Perform drug reconciliation, generates accountability, and reconciliation reports and submits project close-out reports
Acts as a liaison between clients and Clinigen CSM.
Partner with other team members in Operations to maintain and track outstanding requests and improve the inventory database