Clinical Trial Drug Supply Specialist - Remote | WFH Job at Get It Recruit - Transportation, Aurora, CO

S2JTM0RSZ0xQRkl1cm9veHoyUGlKSEp2aFE9PQ==
  • Get It Recruit - Transportation
  • Aurora, CO

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,

Similar Jobs

Hilltop Holdings

Fraud Investigator II Job at Hilltop Holdings

 ...days of PTO, 401k Matching, Health Benefits, and more! The Investigator II will have minimal supervision under manager or designee, accumulates...  ...with business units and initiates contacts with outside corporations and agencies. Attend area Intel Meetings as directed.... 

Erb Industries Inc.

JOB FAIR/IMMEDIATE ONSITE HIRING $13.75-$17/HR Job at Erb Industries Inc.

 ...Job Description Job Description SAME DAY HIRING FAIR Wed 2/7/24, Thu 2/8/24, and Fri 2/9/24 9a-12p and 1p-430pm until positions are...  ...Safety Way, Woodstock, GA 30188. Due to demand we are doing on the spot hiring. Calls will not be accepted, please see below and follow... 

Jobot

low voltage technician Job at Jobot

 ...low voltage security technician needed This Jobot Job is hosted by: Julie Dunn Stewart Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume. Salary: $28 - $33 per hour A bit about us: We are a 20 year established and... 

Herr Industrial

Mechanical Designer/Design Engineer Job at Herr Industrial

 ...Design and prepare drawings for use by the fabrication and installation departments and provide layout and design for proposed projects...  ...operation and maintenance manuals of finishing systems. Miscellaneous engineering projects and tasks are assigned as needed.... 

Robert Half

Executive Assistant Job at Robert Half

 ...Job Description Job Description We are offering a long-term contract employment opportunity for an Executive Assistant in Chattanooga, Tennessee. This role is situated in the manufacturing industry and provides a hybrid work arrangement, entailing in-office and remote...