Project Coordinator, Extended Outsourcing

About the Role

Almac Group is seeking a Project Coordinator – Extended Outsourcing for our Groton, CT location. This role supports client global clinical supply through transactional and project activities.

Fully Onsite in the Groton, CT Location.

Key Responsibilities

• Utilize client’s tools and systems (e.g. CSDS, Clementine, GDMS, CAIS, LIMS, SharePoint, etc.) to provide transactional support.
• Enter/verify information in client’s validated systems.
• Document management of both physical and electronic documents in a GMP environment.
• Generate reports/documents from multiple systems.
• Manage shared mailbox correspondence and action items.
• Create protocol specific document folders and compile e-documents.
• Data entry in non-GMP systems, such as SharePoint.
• Partner with client staff in functional areas to perform transactional and project activities within assigned scope of work, including:
• Distribution Support (via raising shipments/tracking or assisting with tasks such as transfers of material).
• Monitoring of stock and usage to support client programs and protocols.
• Create and maintain Drug Plans and API trackers.
• Review and/or approve documentation to ensure quality in a GMP environment.
• Provide training support for the department, either in a mentoring or system administrator capacity.
• Printing of supplies/materials/labels used in operations or expiry updates.
• Provide TMF services.
• Performing quality reviews on documentation in validated Trial Master File system.
• Track and create metrics of events in client quality management system.
• Provide support for audit or inspection requests.
• Perform blinding verification tasks within sample lab on client site.
• Provide job-specific Key Performance Indicators (KPIs) to Operations Supervisor or Project Group Manager.
• Log all billable time against correct program codes and cost centers in a time tracking spreadsheet.
• Contribute to SOP revisions, efficiency projects, or client initiatives.

Requirements & Tech Stack

• High School Diploma/GED and equivalent work experience required.
• Working in ERP computer systems.

Qualifications

Required Experience / Education:

• Bachelor’s with 6+ months customer and/or community service experience OR an Associate degree with 2+ years’ work experience OR HS / GED with 4+ years’ work experience.

Preferred Experience / Education:

• Bachelor's Degree in Science or business-related field preferred.
• Knowledge of Pharmaceutical inventory management systems preferred.
• Pharmaceutical or clinical supplies industry experience.
• Project management experience within a manufacturing environment preferred.