We are seeking a dedicated and proactive Senior Study Specialist to join our clients Global Study Operations team.
Our client is a global pharmaceutical company focused on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
This role is critical in overseeing site management, vendor management, and other essential tasks to ensure the successful execution of clinical trials. The position offers an exciting opportunity to contribute to studies impacting patient safety, data integrity, timelines, quality, and budget.
Job Type: Temporary Contract – Inside IR35
Duration: 6 months with a possibility of extension
Location: London Central
Work Model: Hybrid (2 Days a week onsite)
Visa Sponsorship: No
Job Reference: BBBH 25471
In this role you will work with a team consisting of approximately 30 members, while collaborating with a global team comprising around 70 people. The Study Specialist will significantly contribute to team tasks and overall support.
Key Responsibilities:
- Contribute to and lead the oversight of site monitoring, site management, and vendor management.
- Develop and review study-specific documentation as delegated by the Study Manager.
- Manage country and site feasibility assessments.
- Support the collection and tracking of regulatory documents.
- Oversee essential document collection for study life-cycle management.
- Develop site and investigator training materials; present at investigator meetings as needed.
- Ensure timely updates to ClinicalTrials.gov.
- Facilitate investigator payments and manage site set-up processes.
- Provide administrative assistance for internal and external meetings, including investigator meetings.
- Oversee Global Study Operations document translations and manage signature processes.
- Address and resolve site-related issues and risks in collaboration with CROs.
- Support the Clinical Trial Insurance process.
- Ensure timely delivery and handling of investigational products (IP) to sites.
- Attend and represent the Global Study Operations team in various meetings, taking minutes as requested.
- Manage essential documents in the Trial Master File (TMF) and support risk identification and mitigation.
Ideal Candidate Profile:
- 3-5 years of experience working for or on behalf of a Sponsor. Experience in Phase 1-3 trials is essential, with a preference for those with experience in rare diseases and/or gene therapy.
- Familiarity with Microsoft Office and clinical trial systems (e.g., eTMF, eCRF, CTMS).
- Preferably a background in biopharma, but candidates from CRO, academia, NHS, or non-commercial backgrounds with Sponsor-level experience will also be considered.
Submit your CV (in a Microsoft Word format) today!
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