Hybrid Project Manager, Pharma Ops | cGMP & Clinical Trials

Clinigen; Malvern (Chester County); Hybrid; USD 90,000 - 130,000; 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, a global specialty pharmaceutical and services company, seeks a Project Manager, Operations to lead client projects from inception to delivery in alignment with cGMP standards. The hybrid role requires 3 days in the Malvern, PA area, with travel to sites as needed.

You will coordinate timelines, packaging, distribution, and inventory management while ensuring quality and regulatory compliance. Ideal candidates have a degree and experience in project management within clinical trials,

Qualifications

• Bachelor's degree and/or equivalent work experience in 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 all client project details including packaging, labeling, dispensing, and distribution with 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 documentation.
• Provide distribution solutions for cold chain and controlled temperature shipments.
• Use PM tools to ensure time management and risk assessment timelines.
• Perform drug reconciliation and submit project close-out reports.
• Act as liaison between clients and Clinigen CSM; travel may be required.
• Partner with Operations team to track outstanding requests and improve inventory database.

Skills

Project management

cGMP knowledge

Clinical trial management

Communication skills

Problem solving

Education

Bachelor's degree or equivalent

Tools

PM software

Job description

Clinigen, a global specialty pharmaceutical and services company, seeks a Project Manager, Operations to lead client projects from inception to delivery in alignment with cGMP standards. The hybrid role requires 3 days in the Malvern, PA area, with travel to sites as needed.

You will coordinate timelines, packaging, distribution, and inventory management while ensuring quality and regulatory compliance. Ideal candidates have a degree and experience in project management within clinical trials,