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Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)
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Clinigen

Project Manager - Operations (Pharma)

Malvern, PA, United States

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Job details

Posting language: English
Posted: Nov 9, 2026

Original job description

About Project Management at Clinigen:

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

To be successful in this role you should have:

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

Your role at Clinigen:

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. Domestic travel to clients may be deemed necessary and will be evaluated on a case-by-case basis.
Partner with other team members in Operations to maintain and track outstanding requests and improve the inventory database

We’re excited about you if you have:

Flexible and adaptable to changing situations
Posses 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

Benefits

While at Clinigen, you’ll enjoy:

The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles. The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen. The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

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

EEO. Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.

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