Clinical Supply Associate Project Manager

$45,000 - $45,000/Yr

Caligor Coghlan Clinical Supply Services - Bastrop, TX

Full-time

Onsite - Bastrop, TX

About the position

The Clinical Supply Associate Project Manager is responsible for planning, implementing, and coordinating the daily activities related to clinical supplies for early phase and distribution-only clinical research programs involving investigational drugs. This role involves direct oversight of project planning, production scheduling, procurement coordination, and ensuring compliance with Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs). The position requires effective communication with clients and internal teams to manage expectations and resolve complex supply issues, ensuring that project objectives, timelines, and budgets are met.

Responsibilities

• Determine scope and operational requirements of the project from the quotation and customer supplied information.
• Hold a kickoff meeting with the sponsor at project initiation to ensure all parties are aware of the project scope and responsibilities.
• Work with third parties involved in projects to define CalCog responsibilities within the project scope.
• Perform risk assessments at project initiation and continually assess throughout the project.
• Build, manage, and update the comprehensive project plan for each project under management.
• Maintain the project plan to reflect the current status of tasks associated with the project.
• Create and disseminate packaging and distribution summaries to ensure all departments and sponsors are aware of responsibilities and requirements.
• Lead project team activities at all stages, coordinating tasks to ensure completion according to the project plan timelines.
• Create change orders for additional services or budget exhaustion and obtain client approval.
• Manage the flow of return clinical trial materials (CTM) and ensure final accountability and destruction.
• Record, collate, and report customer-specific KPIs, implementing performance improvement plans as necessary.
• Create invoices for monthly services on time as per the invoicing schedule.

Requirements

• Bachelor's Degree in Biology/Life Sciences or equivalent combination of education and 3+ years of pharmaceutical research experience.
• Ability to organize, plan, and prioritize tasks within a high volume, varied workload.
• Ability to interpret and apply cGMP and GCP knowledge.
• Strong interpersonal skills to manage, motivate, and influence work behaviors.
• Proven experience in managing and organizing a team.
• Open-minded, empathetic, and adaptable to different cultures among international clients and projects.
• Flexible, enthusiastic, and highly motivated to work in a challenging environment.
• Proficient in Microsoft Office applications (Word, Excel, Outlook).
• Attention to detail and statistical aptitude.