Clinical Supplies and Logistics Manager
San Diego, CA
We are currently searching for a skilled professional to join a well-known client’s team as Clinical Supplies and Logistics Manager in Del Mar, California. The Clinical Supplies and Logistics Manager role will report to the Associate Director of Quality Control and will support the Clinical Supplies Team’s activities related to Clinical Trial Material. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Prepare Clinical Trial Material supply forecasts based on projected needs of clinical trial study protocols
- Coordinate supply of Clinical Trial Material based on study and drug forecasts
- Manage Clinical Trial Material both internally and with distribution partners
- Work collaboratively with other departments for the creation and approval of product labeling
- Manage labeling and packaging operations with vendors
- Negotiate supply and technical agreements
- Act as primary liaison between personnel and contractors on assigned projects
- Support the development, implementation, and maintenance of automated supply systems
- Process manual orders for Clinical Trials Material to be shipped by contractors for all studies operating outside of automated supply systems
- Maintain clinical supplies inventory for assigned projects by interfacing with vendor to ensure inventory systems are up-to-date and final product reconciliation is accurate
- Develop Standard Operating Procedures related to inventory management, distribution, transportation, and disposition of returned or unused materials
- Ensure that key supply project milestones are met while maintaining open communication with internal and external customers and partners
- Select and manage vendors for the supply of centralized services
- Oversee vendors from start-up to close-out, including budget negotiation process
- Coordinate the provision of clinical lab kits to sites, tracking of samples back to labs, delivery of clinical test results, and sample storage and destruction as required by protocol
- Ensure consistency of processes and documentation across multiple studies
- Lead efforts in designing and implementing off-site inventory storage for disaster recovery
- Maintain on-site storage equipment in validated state
- Track and manage temperature data associated with shipments of clinical drug supplies
- Ensure that all documentation of product and test article accountability is present in trial master file and ready for submission
- Coordinate and lead regular clinical supplies logistics meetings with cross-functional teams
- Performs other duties as required
- At least 5 years Clinical Operations experience
- Working knowledge of import, export and IATA regulations
- Experience in supply and cold chain management
- Strong understanding of CFR and ICH guidelines and regulations
- Proficiency in Microsoft Word, Excel, and Project
- Bachelor’s Degree with strong emphasis on science
- Master’s Degree preferred
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.