Specialist II, Clinical & Ancillary Supplies Services

Company: Labcorp
Location: Burlington
Posted on: January 21, 2023

Job Description:

The Specialist II, Clinical & Ancillary Supplies Services will independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a simple global study. Act as contact with study team during clinical and ancillary start-up activities including input to the development of Clinical Trial Supplies Plan or Clinical Trial Supply Flow for a given group of countries in a region or within a region or for a simple global study. - Perform and coordinate label review and country translations according to set procedures. - Responsible for working with project team to ensure the required documents and processes related to supply management are communicated and obtained. Where appropriate be the key contact for importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up. - Provide consultancy with regard to clinical & ancillary supply distribution strategy for the assigned region or for a simple global study. - Responsible for maintenance of project specific clinical & ancillary supply logistics. - Work closely with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics.

What to Expect

• Understand and follow, provide input to project specific and Labcorp Drug Development policies and procedures
• 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 a simple global study at client and internal project meetings
• Liaise with operational project team regarding project issues (i.e., participate in team meetings)
• Liaise with Sponsor and Labcorp Drug Development regulatory regarding clinical supply related submission requirements
• Attend ongoing training, project specific requirements and as may generally be required
• Provide milestone information for the region
• Review the protocol to confirm if Labcorp Drug Development / other vendor can import all the supplies required in the region.
• As necessary, provide information to GRS to request import licenses and manage these -import licenses -as needed for the protocol - -
• Coordinate and track shipments to sites required -for each protocol as appropriate in the region
• As appropriate, manage and communicate with the couriers and brokers in each of the participating countries in the designated region(s)
• As appropriate, support payment process to the couriers and brokers in each of the participating countries in the designated region(s)
• As appropriate review commercial invoices and airway bills according to each individual shipment and country
• Update the Importation Process for the region(s) as needed
• Liaise with all the operational groups (Project Management, Clin Ops, GSS, GRS) at Labcorp Drug Development in order to provide status reports
• Work with GRS on obtaining, understanding and interpreting country-specific requirements and regulations for the importation of clinical trial supplies.
• Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
• Manage the regions drug supply vendor activities as applicable
• Oversee importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
• Develop, review and approve drug supply labels as applicable
• Coordinate ancillary supply logistics with various vendors or internal team
• Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes
  • Assist with preparation of materials for formal client/industry presentations and for internal training assignments
  • Conduct QC of documents as required by the process
  • Undertake literature and internet searches as required
  • Mentor other team members
  • Perform other duties as assigned by management
    
    Education / QualificationUniversity/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 3 years work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and FDA, GMP regulations.
    
    Experience
    • Minimum of 3 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 1 year of clinical and ancillary supplies management responsibility.
    • Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents
    • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
    • Good organizational and time management skills
    • Excellent communication / writing skills
    • Strong computer skills with an ability to access and leverage technology alternatives
    • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
    • Self-motivation with the ability to work under pressure to meet deadlines
    • Works well independently as well as in a team environment
    • Detail and process oriented
    • Positive attitude and approach
    • Multi-tasking capability
    • Ability to work independentlyLabcorp is proud to be an Equal Opportunity Employer:
      
      As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
      
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Keywords: Labcorp, Burlington , Specialist II, Clinical & Ancillary Supplies Services, Healthcare , Burlington, North Carolina