Hybrid Pharma Operations Project Manager (cGMP)

Clinigen; Malvern (AR); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Dental insurance

Employee assistance program

Employee discount

Health insurance

Health savings account

Life insurance

Paid holidays

Paid time off

Parental leave

Professional development assistance

Referral program

Vision insurance

Job summary

Clinigen is seeking a Project Manager, Operations in a hybrid role with three days in the office, ideally located near Malvern, PA, USA. You will oversee overall project direction, coordination, and execution for client projects, ensuring adherence to cGMP standards and company strategies.

You will manage timelines, packaging, labeling, distribution, inventory thresholds, and risk assessments while collaborating with clients and the Clinigen CSM team.

Qualifications

• Bachelor’s degree or equivalent in knowledge of cGMP and Clinical Trial Management.
• Experience in the phases, techniques, and tools of project management.

Responsibilities

• Create and maintain a project timeline based on client needs.
• Coordinate, manage and review client-specific project details including packaging, labeling, dispensing, and distribution of clinical trial material with maximum 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 documentation.
• Provide distribution solutions for cold chain supplies and controlled-temperature shipment needs.
• Utilize project management tools to ensure time management in planning, evaluation, and risk assessment timelines.
• Perform drug reconciliation, generate accountability, and reconciliation reports and submit project close-out reports.
• Act as liaison between clients and Clinigen CSM; travel to clients may be necessary.

Skills

Project management

Communication

Time management

Education

Bachelor’s degree

Tools

Project management tools

Job description

Clinigen is seeking a Project Manager, Operations in a hybrid role with three days in the office, ideally located near Malvern, PA, USA. You will oversee overall project direction, coordination, and execution for client projects, ensuring adherence to cGMP standards and company strategies.

You will manage timelines, packaging, labeling, distribution, inventory thresholds, and risk assessments while collaborating with clients and the Clinigen CSM team.