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Pivot Search
York
Job Description Study Manager Team Lead Summary: The key responsibility of a Small Molecule Study Manager Team Lead is to serve as a Study Manager for both regulatory and non-regulatory studies. In addition, the Team Lead will directly manage a team of Study Managers. Requirements: BSc in Chemistry or related subject (required) 5+ years study
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Job Source: VRS RecruitmentVRS-UK
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A leading provider of laboratory services to global clinical trials, our client delivers bioanalytical and toxicology programmes from their state-of-the art facility in York. Partnering with customers across the bioanalytical sector working to optimise programs during the crucial stage of the drug discovery and development process, they give techni
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We have an exciting new opportunity for a Study Manager Team Lead to join a leading international CRO based in the North Yorkshire area. As the Study Manager Team Lead you will be responsible for directly line managing a team of Study Managers for regulatory and non-regulatory small molecule bioanalytical studies. KEY DUTIES AND RESPONSIBILITIES:
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Job Source: Sterling CrossYork, England, United Kingdom
Study Manager Team Lead
Summary:
The key responsibility of a Small Molecule Study Manager Team Lead is to serve as a Study Manager for both regulatory and non-regulatory studies. In addition, the Team Lead will directly manage a team of Study Managers.
Requirements:
BSc in Chemistry or related subject (required)
5+ years study management experience in GLP/GCP bioanalysis
Management of 10+ studies at any one time
Demonstrated ability to handle escalations
RESPONSIBILITIES
Study Management.
Ensure studies adhere to company SOPs, policies, protocols, study plans, analytical methods, and regulatory standards.
Act as the departmental lead in Bioanalytical activities, collaborating with Sponsor/Client/internal teams for assigned studies.
Oversee LC-MS/MS method development and troubleshooting.
Review protocols, study plans, reports, SOPs, or scientific papers as needed.
Monitor study-specific budgets and operational costs effectively.
Contribute to the generation of proposal amendments as necessary.
Leadership.
Ensure effective performance management for teams and individuals, including clear definition of roles, responsibilities, and objectives.
Manage instances of below-standard performance or behaviour according to appropriate procedures.
Provide leadership to facilitate the effective performance of teams and individuals, ensuring alignment with monthly operational schedules and meeting company commitments and client expectations.
Keep management and the Site Leadership Team fully informed in a timely and transparent manner about day-to-day operations, progress toward established goals, and any deviations from company objectives.
Quality.
Document and complete quality documentation, including Quality Issues, CAPA, deviation, and change control, within specified timeframes.
Take the lead in updating procedures and organizing necessary training in response to changes or updates to regulatory and industry standards affecting the department.
Bioanalytical Team Lead jobs in York, England, United Kingdom
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