Biosample Operations Specialist

Reed ,
Welwyn Garden City, Hertfordshire
More Details
Contract Type: Contract
Salary: £310 per day

Overview

Biosample Operations Specialist Our prestigious client based in Welwyn Garden City are looking for a Biosample Operations Specialist to work in their ever growing successful global team. The company are a Global organisation specialising within Medical science. They have been established for many years, providing a worldwide presence within the Pharmaceutical industry. Job Purpose: Drives alignment of study and project level strategies. Is responsible for the delivery and implementation of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP. Ensures project level consistency for biosampling across studies and is the primary point of contact within Biosample Operations for project, clinical and study teams. Delivers expert input on strategic direction and operational considerations. Leads or contributes to innovation and continuous improvement activities. Primary Responsibilities and Accountabilities: To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme. To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels. To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery. To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable. Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives. To actively promote knowledge sharing within Clinical Development Expert Resources and across studies within a project by partnering with stakeholders. To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders. Education / Qualifications: Life sciences degree or equivalent qualification. Experience, Skills, Knowledge Significant experience implementing clinical trials - required. Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi centre clinical studies, - preferred. Demonstrated knowledge of ICH GCP. Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples. Demonstrated leadership skills. Proven ability to successfully achieve results within a multi-cultural and geographically diverse matrix environment Proven ability to influence effectively and confidently within a matrix environment. Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention. For more information and to register your interest for this role please apply and we will be back in touch with you. If you are unsuitable for this vacancy then REED has many other opportunities we could discuss with you. Good Luck with your application

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