The Clinical & Ancillary Supplies Services team has an opportunity available for a Senior Specialist, Clinical & Ancillary Supplies Services!
This position will be office based in Princeton, NJ.
The Senior Specialist, Clinical & Ancillary Supplies Services will
coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services. The Senior Specialist, Clinical & Ancillary Supplies Services will support these services to both internal and external clients.
• Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies
• Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a large global study.
• Provide local support with clinical and ancillary supplies start up activities and related project feasibility
• Act as a subject matter expert (SME) related to import, export and labeling requirements.
• Work with staff in Clinical Trial Design & Strategy, Vendor Management, Quality Assurance, Business Development and Operations, to provide relevant clinical and ancillary supply data critical to the ability of the organization to develop plans for the successful implementation and conduct of global clinical trials.
• Assure that pre-study, drug supply and labeling processes comply with applicable guidelines and regulations and fulfill client and Covance requirements
• Provide logistical support for clinical and ancillary supply coordination
• Provide input into business development activities
• Act as a subject matter expert (SME) in client focused clinical and ancillary supply workstreams
• Understand and follow, provide input to and training of related project specific and Covance policies and procedures
• Direct line management responsibility for Clinical and Ancillary Supply Services team members: the recruitment, training/development, allocation, supervision, utilization and performance review of assigned personnel
• Effectively network with others throughout Covance
• Serve as primary liaison between Clinical & Ancillary Supply Services, operational project teams, Covance Laboratory Services (CLS), distribution vendors, client distribution units, packaging and labeling vendors or assign relevant staff to carry out this function
• Liaison with project teams and department members regarding issues of compliance with ICH/GCP, GMP, project plans, and Covance SOPs
• Oversee coordination of study related Clinical and Ancillary Supply activation and maintenance components including Labels/Supply, Import/ Export requirements, ancillary supply management
• Develop project specific plans for the Clinical and Ancillary supply component of assigned studies
• Represent Clinical and Ancillary supplies component within a region or for complex global studies at client and internal project meetings
• Anticipate and monitor project requirements and institute appropriate actions to ensure timelines and budget needs are met
• Contribute to the development of processes, procedures, tracking systems and IT solutions for Clinical and ancillary supply activities
• Assist in the preparation and presentation of services, costings and proposals for new business
• Management of relevant portion of project budgets, including input into preparation of utilization reports (projected and actual) and implement measures to ensure accurate billing
• Interact with internal and external work groups to evaluate and forecast workload and resource needs
• Present at internal and external meetings including client meetings
• Ensure appropriate communication on project-related matters with the clinical project team
• Provide clinical and ancillary supply project related milestone information
• Review and, in accordance with Covance standards and assigned authority, approve employee expense reimbursement.
• Clinical trial supply and ancillary supply coordination:
Provide consultation pertaining to clinical & ancillary supplies: the labeling, tracking, specific national requirements, importation
Review IxRS specifications
Ensure triggering of drug shipments to investigational sites
Manage Drug distributor
• Review of and input to authority inspection and client audit findings or CAIRs
• Develop, update and/or refine SOPs
• Remain current with and provide updates to regional and local regulatory requirements related to clinical and ancillary supplies.
• Remain current with industry innovations and advances, especially pertaining to clinical and ancillary supply matters so as to include relevant advances and technology into the design of trial strategies.
• Perform other duties as assigned by management
In lieu of the above requirements, candidates with > six (6) years clinical research experience including monitoring in the pharmaceutical or CRO industries will be considered