Clinical Trial Supply Chain Manager
2 weeks ago
CPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.
The Clinical Trial Drug Supply Specialist will play a crucial role in overseeing regulatory and investigational product functions essential for our clinical studies. This position entails managing both internal workflows and external partnerships, including Contract Manufacturing Organizations (CMOs), to ensure the supply, labeling, production, and distribution of products adhere to regulatory standards.
Key Responsibilities:
- Oversee Qualified Person responsibilities and regulatory requirements.
- Ensure adherence to FDA guidelines and other regulatory bodies.
- Foster relationships with regulatory organizations.
- Prepare and file necessary regulatory documentation.
- Provide regulatory guidance to operational teams.
- Submit trial-related information to public registries.
- Coordinate with Institutional Review Boards (IRBs) and Ethics Committees (ECs).
- Manage all components of investigational product supply for trials.
- Establish and document supply chain protocols.
- Monitor stock levels and oversee distribution processes.
- Collaborate with Quality Assurance for batch record validations.
- Address product complaints and manage temperature deviations.
- Ensure thorough documentation of investigational product supply activities.
- Assist in the selection of drug supply vendors.
- Facilitate the design and implementation of Interactive Response Technology (IRT) systems.
Qualifications:
- Bachelor's degree in health or life sciences.
- A minimum of 5 years of experience in the pharmaceutical sector, with at least 3 years in regulatory oversight.
- Experience in product supply logistics is advantageous.
- Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and related regulations.
- Proficient in MS Office and Electronic Data Capture (EDC) systems.
- Exemplary leadership and communication abilities.
Compensation: $90,000 - $102,000 annually
About CPC Clinical Research:
We are a premier academic research organization specializing in the design and management of clinical trials across diverse therapeutic areas. With over three decades of expertise, we have successfully conducted numerous clinical studies focusing on cardiovascular health, wound healing, and diabetes management.
We provide a comprehensive benefits package, including 401(k) matching, paid holidays, vacation days, and sick leave, all within a collaborative work environment.
Equal Opportunity Employer:
CPC Clinical Research is committed to providing equal employment opportunities to all individuals, regardless of race, gender, color, religion, national origin, disability, or any other status protected by law. Qualified candidates will be selected based on job-related criteria.
-
Clinical Trial Supply Chain Specialist
7 days ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob OverviewCPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.The Clinical Trial Drug Supply Specialist will oversee regulatory and investigational product management to facilitate our clinical studies. This role involves supervising both internal protocols and external partners, including...
-
Clinical Trial Supply Chain Specialist
2 weeks ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob OverviewCPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.The Clinical Trial Drug Supply Specialist will oversee the management of regulatory and investigational product activities essential for our clinical studies. This role involves supervising both internal processes and external...
-
Senior Clinical Trial Manager
4 days ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob DescriptionJob Summary:CPC Clinical Research is seeking an experienced Senior Clinical Trial Manager to lead and manage clinical trials site operations. The ideal candidate will have a strong background in clinical research, excellent communication and organizational skills, and the ability to work independently with minimal supervision.Key...
-
Senior Clinical Trial Manager
4 days ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob DescriptionJob Summary:CPC Clinical Research is seeking an experienced Senior Clinical Trial Manager to lead and manage clinical trials site operations. The ideal candidate will have a strong background in clinical research, excellent communication and organizational skills, and the ability to work independently with minimal supervision.Key...
-
Clinical Trial Master File Specialist
1 week ago
Aurora, Colorado, United States CPC Clinical Research Full timePosition Overview We are looking for a dedicated Trial Master File Associate to become a vital part of our organization.Key Responsibilities:Assist in the creation and oversight of Trial Master File systems for clinical studiesManage the uploading of study documentation into electronic TMF platformsGuarantee the prompt and precise organization of essential...
-
Clinical Trial Manager I
3 days ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob DescriptionJob Summary:CPC Clinical Research is seeking a highly skilled Clinical Trial Manager I to serve as the primary point of contact for clinical trials site operations. As a key member of our team, you will be responsible for ensuring the smooth execution of clinical trials at our partner sites.Key Responsibilities:Site Operations Management:...
-
Trial Master File Coordinator
2 weeks ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob Overview We are looking for a dedicated Trial Master File Associate to become a vital part of our organization.Key Responsibilities:Assist in the creation and oversight of Trial Master File systems for clinical studiesManage the upload of study documentation into electronic TMF platformsGuarantee the prompt and precise organization of essential...
-
Senior Supply Chain Analyst
1 week ago
Aurora, Colorado, United States Brambles Full timeCompany OverviewBrambles is a global leader in supply chain logistics, specializing in the management of pallets, crates, and containers. With a workforce of 11,000 employees operating across more than 55 countries, we are committed to enhancing the efficiency and sustainability of supply chains worldwide. Our innovative share-and-reuse business model is...
-
Senior Supply Chain Analyst
2 weeks ago
Aurora, Colorado, United States Brambles Full timeCompany OverviewBrambles is a global leader in supply chain logistics, specializing in the provision of reusable pallets, crates, and containers. With a workforce of over 11,000 employees across more than 55 countries, we are committed to enhancing the efficiency and sustainability of supply chains worldwide.Position OverviewThe Senior Analyst, Supply Chain...
-
Clinical Trials Coordinator
1 week ago
Aurora, Colorado, United States University of Colorado Full timeUniversity of Colorado Anschutz Medical Campus School of Medicine | Department of Medicine | Division of Hematology Job Title: Clinical Research Coordinator (Entry – Senior Level) Position: # – Requisition: #33948 Job Overview: Clinical Research Coordinators engage in research activities that may encompass patient-centered studies or...
-
Clinical Trials Coordinator
2 weeks ago
Aurora, Colorado, United States University of Colorado Full timeUniversity of Colorado Anschutz Medical Campus School of Medicine | Department of Medicine | Division of Hematology Job Title: Clinical Research Coordinator (Entry – Senior Level) Position: # – Requisition: #33948 Job Overview: Clinical Research Coordinators are responsible for managing clinical research activities that may involve...
-
Logistics and Supply Chain Coordinator
1 week ago
Aurora, Colorado, United States Xvivo Perfusion Full timePosition OverviewXVIVO Perfusion, a leader in medical technology specializing in ex vivo organ preservation, is seeking a Logistics and Supply Chain Coordinator. This role is essential in ensuring the seamless availability of critical medical equipment through effective procurement and strategic planning. Your meticulous attention to detail and analytical...
-
Clinical Trials Coordinator
2 weeks ago
Aurora, Colorado, United States University of Colorado Full timeUniversity of Colorado Anschutz Medical Campus School of Medicine | Department of Medicine | Division of Hematology Job Title: Clinical Research Coordinator (Entry – Senior Level) Position: # – Requisition: #33948 Job Overview: Clinical Research Coordinators are responsible for executing research activities related to human subjects....
-
Senior Supply Chain Optimization Analyst
7 days ago
Aurora, Colorado, United States Brambles Full timeCompany OverviewBrambles operates a global network that facilitates the movement of goods through its extensive inventory of pallets, crates, and containers. With a workforce of 11,000 employees across more than 55 countries, we are committed to enhancing supply chain efficiency while minimizing environmental impact through our innovative share-and-reuse...
-
Clinical Operations Manager II
2 days ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob DescriptionJob Summary:CPC Clinical Research is seeking an experienced Clinical Operations Manager II to oversee clinical operations management activities, define and monitor project scope, timelines, and deliverables, and provide expert advice in the design, writing, and/or review of all project-related essential documents.Key Responsibilities:Project...
-
Clinical Trial Finance Coordinator
2 weeks ago
Aurora, Colorado, United States University of Colorado Full timePosition Title: Post Award Finance Specialist (Research Services Professional) OPEN RANK Department: School of Medicine Department of Surgery Job Overview: This role is essential for the financial oversight and management of grant and clinical trial activities within the Department of Surgery's post-award program. The incumbent will provide critical...
-
Clinical Research Associate II
2 days ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob SummaryWe are seeking a highly skilled Clinical Research Associate II to join our team at CPC Clinical Research. As a key member of our clinical trials team, you will be responsible for ensuring the smooth execution of clinical trials, from site initiation to close-out.Key ResponsibilitiesSite Monitoring: Conduct regular site visits to ensure compliance...
-
TMF Management Associate
2 weeks ago
Aurora, Colorado, United States CPC Clinical Research Full timeJob Overview We are looking for a dedicated Trial Master File Associate to become a vital part of our organization.Key Responsibilities:Assist in the creation and oversight of Trial Master File systems for clinical studiesUpload essential study documentation into electronic TMF platformsGuarantee the prompt and precise organization of critical documentsWork...
-
Supply Chain Specialist
5 days ago
Aurora, Colorado, United States Central Garden & Pet Full timeJob SummaryWe are seeking a highly motivated and detail-oriented Warehouse Associate to join our team at Central Garden & Pet. As a key member of our supply chain team, you will be responsible for ensuring the efficient and accurate processing of merchandise, from receiving and storing to shipping and delivery.Key ResponsibilitiesProcess transactions...
-
Grant Management Finance Specialist
7 days ago
Aurora, Colorado, United States University of Colorado Full timeUniversity of Colorado Anschutz Medical Campus Department: School of Medicine Department of Surgery Job Title: Post Award Finance Specialist (Research Services Professional) OPEN RANK Position #: – Requisition #:34535 Job Overview: The Post Award Finance Specialist plays a vital role in the financial oversight and management of grant and...