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Team Leader-Clinical Trials Sample Management posted by ACM Global Laboratories

York, City of York

Job Description

ACM Global Laboratories are recognised as a leader in both medical diagnostic and global clinical trial testing services. With wholly owned facilities in New York, England, Shanghai China, Mumbai India and Singapore, we operate in more than 65 countries around the globe. Our full-time staff of laboratory experts performs more than 30 million tests annually, spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

A super opportunity to join our York based site. Our Team Leaders lead by example and mentor their team members whilst acting as a support to the Managers. The Clinical Trials Specimen Management team are responsible for the handling of clinical trials specimens and their associated data. They manage human biological specimens and perform data entry in a laboratory environment (appropriate PPE and H&S training will be provided). Accuracy, attention to detail, flexibility and a willingness to learn are essential to ensuring that we provide a high level of service to our internal and external clients. All processes will be performed in line with SOPs and appropriate regulatory guidelines and training will be provided. Our Team Leaders lead by example and mentor whilst be their team members whilst acting as a support to the support the Managers.

Job Summary

* Perform receipt, QC checks and onward processing for Clinical Trials specimens

* Drive daily workflow in all CTSM areas through task rotas, team meetings and directing team members

* Act as a mentor and coach to CTSM team.

* Review and provide feedback on study documentation including GLSDs, requisition forms and study protocols on behalf of CTSM to support optimal set up and running of clinical trials studies.

* Work with Study Set up team to validate set up of clinical trials studies

* Support Manager, Specimen Management in line management of CTSM personnel including performance appraisals and disciplinary processes

* Serve as a primary point of contact for internal departments to resolve issues/requests in a timely manner

* Collate specimen management related metrics to aid in forecasting and decision making

* Actively participate in process improvement within the CTSM team by developing methods to improve productivity, service, quality, cost savings, policies & procedures.

* Actively participate in CTSM Team Lead meetings to develop standardization and process excellence within the department

* Aid in the development of Standard Operating Procedures and associated training.

* Participate in Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies.

* Demonstrate initiative in professional self-development to improve job performance to maintain relevant working knowledge of Clinical Trials

* Manage ad-hoc process improvement/remediation projects as required and perform other duties as assigned.

* Guarantee client satisfaction by providing exceptional service through a consistent customer centric approach, focus on precision delivery and flexibility to meet customer expectations.

* Maintain positive working relationships with internal clients including Project Management and Study Support teams and key stakeholders

* Maintain a general working knowledge of Medicines & Healthcare products Regulatory Agency (MHRA), Good Clinical Practice (GCP), ICH and other pertinent regulations.

* Perform all processes in accordance with SOPs and appropriate regulatory bodies

Qualification Requirements

* 5 GCSEs grade C and above or equivalent

* 6-12 months’ experience in a Team Leader capacity

* 6-12 months’ experience within a Clinical environment/role

Reference Number


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