Operations Project Manager - Pharmaceutical Sector

Overview

Clinigen is an expanding global specialty pharmaceutical and services company operating in a regulated international environment to ensure vital medicines are delivered securely and on schedule worldwide. The Operations Project Manager leads client projects through coordination, implementation, and completion, consistently aligning with company strategy and providing high-quality service under strict cGMP standards. This position requires working three days a week onsite in Malvern, PA, and candidates must live close enough to commute.

Key Responsibilities

• Develop and maintain project timelines tailored to client specifications.
• Oversee all project elements concerning packaging, labeling, dispensing, and distribution of clinical trial materials and ancillary supplies, ensuring accuracy.
• Review and authorize documentation related to packaging, distribution, and returns.
• Monitor inventory levels and expiry dates to maintain adequate stock.
• Assist in procurement activities as per client documentation.
• Provide customized distribution solutions for cold chain and controlled temperature shipping requirements.
• Utilize project management resources to ensure effective time planning, risk assessment, and on-time submissions.
• Conduct drug reconciliation, generate accountability and reconciliation reports, and prepare final project close-out documentation.
• Serve as a communication bridge between clients and Clinigen's Client Services Management; occasional domestic travel may be required.
• Collaborate with operations team members to monitor outstanding requests and enhance the inventory database.

Candidate Profile

• Bachelor’s degree or equivalent relevant experience in cGMP principles and clinical trial management.
• Keen understanding of project management phases, techniques, and tools.
• Adaptable and flexible to evolving operational circumstances.
• Detail-oriented and proactive in problem-solving day-to-day challenges.
• Strong interpersonal and listening skills.
• Exceptional time management to perform effectively in a dynamic environment.
• Ability to analyze situations critically, make quick independent decisions, and demonstrate high initiative while working both independently and in teams.

Employee Benefits

At Clinigen, you will benefit from a diverse and inclusive culture valuing different backgrounds and perspectives. Leadership maintains transparency through regular anonymous employee feedback used to enhance company practices. Benefits offered include:

• 401(k) plan with company matching
• Dental, health, and vision insurance
• Employee assistance program and employee discounts
• Health savings accounts
• Life insurance
• Paid holidays, paid time off, and parental leave
• Professional development support
• Referral incentives

Equal Opportunity Statement

Clinigen is an Equal Opportunity Employer dedicated to providing fair hiring opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or other legally protected characteristics.