Clinigen
pharmaceutical
OperationsProjectManager(Pharma)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Operations Project Manager (Pharma) at Clinigen. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. 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”
What You'll Achieve.
ensuring consistency with regards to company strategy, commitments, and goals of providing quality and service in the highest cGMP Standards
Industry & Context.
problem solving of daily operations; critically evaluate situations; making timely and independent decisions
Domestic travel to clients may be deemed necessary and will be evaluated on a case-by-case basis, 3 days in the office, within a commutable distance to Malvern, PA, USA
What They're Looking For.
Must 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
Nice to 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
What You'll Do.
Create and maintain a project timeline based on client needs
manage and review all client specific project details including the packaging
and distribution of clinical trial material and ancillary supplies with maximum attention to accuracy
Review and approve packaging
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
and submission of risk assessment timelines on projects
Perform drug reconciliation
generates accountability
and reconciliation reports and submits project close-out reports
Partner with other team members in Operations to maintain and track outstanding requests and improve the inventory database
How You'll Work.
Team & Collaboration
Partner with other team members in Operations
Communication Scope
interpersonal communication; listening skills
Process & Methodology
project timeline creation and maintenance, project execution, risk assessment, time management, project close-out
Full 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
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