Project Manager - Operations (Pharma)

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

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 specificproject details includingthepackaging, labeling, dispensing, and distributionof clinical trial material and ancillary supplies withmaximumattention 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 temperatureshipment 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 acase-by-casebasis.
• Partner with other team members in Operations to maintainandtrack outstanding requests and improve the inventory database

We’re excited about you if you have:

• Flexible and adaptable to changing situations
• Posses a detailedandproactive approach to management in problem solving of daily operations
• Excellent interpersonalcommunicationand listening skills
• Superior time management skills for working within a fast-pacedenvironment
• Able tocriticallyevaluate situations, and adapt quicklyin makingtimely and independent decisions
• Must demonstrate a high level of initiative and the ability to work well independently and as a team member

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.