Study Manager
1 week ago
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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