Clinical Supply Manager

CPC Clinical Research • Aurora, CO

7d • $70,000 - $90,000 • Remote

About The Position

The Clinical Supply Manager is responsible for timely and accurate provision of investigational product(s) (IP) for CPC Clinical Research clinical trials. This includes managing outsourcing to external vendors [Contract Manufacturing Organizations (CMOs)] to ensure labeling, packaging and shipping of IP in compliance with applicable regulations.

Requirements

• Minimum of 4 years’ experience in the pharmaceutical/biotechnology industry performing global clinical trial supply logistics/management, including supply chain and labeling
• Experience interpreting clinical trial protocols and developing well-planned, accurately forecasted clinical supply forecasts
• Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
• Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.), Electronic Data Capture systems
• Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication
• Ability to work in a fast-paced, complex environment amongst internal and external partners
• Viable applicants will be required to pass a background and education verification check.

Nice To Haves

• Bachelor’s Degree or higher in health or life sciences, preferred

Responsibilities

• Establish and document supply chain for each project according to required scope
• Manage supply planning/forecasting to ensure alignment with study activity and timelines
• Assist Legal with obtaining procurement and/or supply agreements for any required commercially sourced products
• Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid supply issues
• Manage, reconcile, maintain and report an accurate account of IP inventory on-hand, consumption, movements, lot and expiry tracking
• Collaborate with study team and vendors to assure proper distribution of IP to study sites
• Develop excellent working relationships with QA / RA for timely review and approval of batch records for packaging and labeling of IP
• Coordinate with manufacturer counterparts and their vendors to efficiently manage drug supply
• Support organizational innovation in pragmatic trial design and conduct
• Support development of study specific manuals and work with QA to develop supply related training/instructional materials (i.e., Pharmacy Manual, Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.)
• Participate in relevant team meetings providing clinical supply status reports
• Follow up on reported Temperature Excursions and/or Product Complaints from sites/depots
• Ensure expiry extensions are provided to depot/sites as needed to support continued use
• Manage return and destruction of IP under the direction of RA, with proper documentation of all steps
• Ensure appropriate documentation of IP supply activities are filed in the electronic Trial Master File
• Facilitate the design, review, and approval of IP label text and proofs to meet specific country language(s), translations and regulatory requirements
• Facilitate the development, review, and approval of supply packaging configurations and specifications
• Plan and coordinate Vendor activities for scheduling and production of labels and primary/secondary packaging of IP
• Liaise with appropriate parties to ensure adequate IP supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Batch Release Certificate, Compliance, etc.)
• Coordinate expiry date extensions and re-labeling operations, when applicable
• Manage maintenance of appropriate quantity of retain samples

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 10 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level