Job Description
We are seeking a passionate and dedicated Clinical Trial Drug Supply Specialist to join our team in Aurora, CO. In this role, you will play a pivotal role in managing regulatory and investigational product (IP/IMP) activities supporting clinical trials. You'll be responsible for overseeing internal processes and coordinating with external partners, ensuring compliance with regulatory standards throughout the lifecycle of clinical trials.
Key Responsibilities:
Regulatory Responsibilities:
Manage duties related to Qualified Person and Importer of Record responsibilities.
Ensure adherence to regulatory requirements set by the Food and Drug Administration (FDA) and other relevant agencies.
Maintain strong relationships with regulatory agencies both domestically and internationally.
Act as a liaison between regulatory bodies and other relevant stakeholders.
Maintain accurate and up-to-date documentation, preparing regulatory templates for distribution to clinical sites.
Support Operations teams in ensuring trial compliance with all regulatory standards.
Report adverse events to regulatory authorities as required.
Review and approve site-level regulatory documents.
Manage trial documentation submissions to central Institutional Review Boards (IRB) or Ethics Committees (EC).
Prepare and submit country-level study applications and periodic reports to health authorities.
Supply Management Responsibilities:
Coordinate IP lifecycle activities including importation, labeling, distribution, and end-of-study destruction.
Establish and maintain supply chain and forecasting strategies aligned with study timelines.
Monitor and manage inventory levels at trial sites and depots, taking preemptive measures to prevent supply issues.
Ensure accurate reconciliation and reporting of IP inventory, facilitating timely distribution to study sites.
Develop strong relationships with Quality Assurance (QA) for batch record approvals and labeling compliance.
Address reported Temperature Excursions and Product Complaints from sites and depots promptly.
Manage IP expiry extensions and oversee return and destruction processes with meticulous documentation.
Ensure comprehensive documentation of all IP supply activities in the Trial Master File.
Support the Legal team in selecting and contracting Interactive Response Technology (IRT) and drug supply providers.
Assist in the design, review, and implementation of IRT systems.
Qualifications:
Bachelor's degree or higher in health or life sciences.
Minimum of 5 years' experience in the pharmaceutical/biotechnology industry, with a focus on international clinical trial regulatory management.
At least 3 years of experience in regulatory management.
Preferred experience in product supply logistics and management.
Strong understanding of clinical trial protocols and safety reporting guidelines.
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) and Electronic Data Capture systems.
Excellent organizational skills with attention to detail.
Effective communication skills, both written and verbal.
Leadership qualities with the ability to resolve conflicts and align teams towards common goals.
Ability to mentor and collaborate effectively in a team environment.
Employment Type: Full-Time
Salary: $ 90,000.00 Per Year
Job Tags
Full time, Remote job,