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Clinical Study Manager

CY Partners
Job LocationNewcastle Upon Tyne
EducationNot Mentioned
Salary40,000 - 55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Clinical Study Manager | Newcastle Upon Tyne | £40,000 to £55,000The Clinical Study Manager will be responsible for management of multiple studies including the planning, implementation, oversight, project management and completion of clinical studies. This role serves as the project lead for studies of moderate to highcomplexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, IVDR, and all Global, National and Local Regulations.The Clinical Study Manager will be capable of reviewing needs of stakeholders, aligning to requirements and designing and implementing a system for effective management and coordination of clinical studies to support their pipeline of products. This is aground-up opportunity to contribute to and execute on a vision of excellence in clinical study management. The Clinical Study Manager must be prepared to build out and manage a highly effective team in concert with the companys product development pipeline.Responsibilities:

  • Accountable for the execution of clinical studies, or assigned portion of clinical studies while optimizing speed, quality and cost of delivery and compliance with standard processes, policies, and procedures.
  • Preparation of all necessary documentation and systems to support the clinical study design.
  • Design, implementation, and management of study database
  • Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials
  • Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
  • Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed Plans and maintains high quality standards to meet compliance requirements.
Requirements
  • Bachelors Degree in Life sciences/ related field or equivalent experience
  • Experience/ knowledge in IVD products and clinical research
  • Minimum 2 years Project management experience or successfully leading a project team
  • Good knowledge of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and ISO 20916:2019
  • Strong communication, interpersonal skills and technical writing
This offers an exciting opportunity for a Clinical Study Manager be a part of a growing company that strives itself on excellence, providing equal opportunities and a fantastic work environment for their staff.

Keyskills :
Clinic ManagementClinicalStudy ManagersManager

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