Clinical Supply Manager

We are looking for a Clinical Supply Manager to join our team!

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.

Clinical Supply Management (General)

• 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 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
• Develop 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, with proper documentation of all steps
• Ensure appropriate documentation of IP supply activities are filed in the Trial Master File

Vendor Management/Oversight

• Participate in vendor qualification and selection processes
• Serve as primary point of contact for third party packaging, distribution, and storage
• Review and assist Legal with the packaging and logistics service agreements
• Provide input, review, and approval of clinical supply language with Vendor study specifications/plans
• Review and, when requested, approve Vendor invoices against contract and identify out-of-scope activities

Packaging and Labeling

• 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/Compliance, etc.)

• Coordinate expiry date extensions and re-labeling operations, when applicable
• Manage maintenance of appropriate quantity of retain samples

IRT (Interactive Response Technology) Systems

• Work with cross-functional team to develop study-specific IRT specifications and requirements
• Perform user acceptance testing (UAT)
• Perform unblinded monitoring of IRT inventory at depots/sites with respect to recruitment

• Lead the development of resupply algorithms for sites, regional depots, country-level depots, etc.
• Monitor IRT to assure resupply generation, etc. occur within defined specifications 

• Manage IRT updates for supply expiration date extensions, addition of new depot inventory, generation of manual re-supply shipments, evaluation of temperature excursions, etc.

• Serve as an escalation point for supply related issues received from sites

Qualifications:

• Bachelor’s Degree or higher in health or life sciences, preferred 
• Minimum of 4 years’ experience in the pharmaceutical/biotechnology industry performing international clinical trial supply logistics/management
• 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
• Experience with Interactive Response Technology (IRT) System design, implementation, user testing and monitoring
• Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.), Electronic Data Capture systems, and IRTs
• Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $75,000 - $90,000 annually

Deadline to Apply: February 1, 2024

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers:

• 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) 
• In-suite exercise and relaxation room
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age forty and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.

Salary : $75,000 - $90,000