Study Manager

1 week ago

York, United Kingdom Albion Rye Associates Full time

Our client is a growing international organization that provides continued opportunities for internal advancement. You will be part of a team that is focused on improving people’s lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growth.


Job Summary:

The Study Manager will play a pivotal role in the planning, execution, and management of clinical research studies within the life sciences domain. This position involves leading cross-functional teams, ensuring compliance with regulatory standards, and maintaining the highest quality of data integrity throughout the study lifecycle.


ATTRIBUTES:


  • Minimum of 4-6 years study management experience in regulated bioanalysis small molecule
  • Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP
  • Experience in a client facing role with the ability to provide high level advice and guidance to clients


RESPONSIBILITIES


Study Management & Collaboration.


  • Act as Study Manager/ Principal Investigator for regulatory and non-regulatory studies.
  • Responsible for generation of Study Plans, Data Transfer Agreements, Analytical Reports and subsequent amendments.
  • Review any protocol, study plan, report, SOP or scientific paper as required.
  • Responsible for addressing all study related internal audit comments.
  • Act as departmental lead with Sponsor/Client/internal teams for Bioanalytical activities conducted on assigned studies.
  • Responsible for generation of Study Plans, Data Transfer Agreements, Analytical Reports and subsequent amendments.
  • Communicates effectively with team members, and ability to listen and discuss ideas in an open and professional manner.
  • Supports new business development activities (BID meetings) as required, including providing information for new sales enquires (RFIs, RFPs).
  • Works closely with Commercial and Management teams to drive new business; seeks out ways to increase scale and scope of the Bioanalytical Services business offering.
  • Can recognize issues and potential issues and can make correct decisions on how to resolve/prevent.
  • Takes lead role in collaborating and integrating with wider group (PMs etc)


What we offer


  • Up to 25% Sign-On/Relocation Bonus Available
  • Sponsorship Opportunity
  • Competitive Pay
  • Comprehensive Benefits Package
  • Career Advancement Opportunities including Apprenticeship

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