Specialist Ii, Clinical - Bogota, Colombia - Labcorp

Descripción

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.

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.

Work closely with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics.

• 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 countryspecific 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

University/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 previous work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and FDA, GMP regulations.

• Previous relevant clinical research experience in a pharmaceutical company/CRO, including 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 a