At a Glance
- Tasks: Support clinical trial teams and manage essential documentation for studies.
- Company: Join TMC, a growing company in the clinical research field.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Mentorship opportunities available for junior staff.
- Why this job: Make a real impact in clinical trials while developing your skills in a dynamic environment.
- Qualifications: Experience in administrative support and knowledge of clinical trials preferred.
The predicted salary is between 36000 - 60000 £ per year.
Due to expansion, TMC are looking to hire a Senior Clinical Trial Administrator (Sr CTA). The role is to perform daily administrative activities and support the Project Manager(s), Project Director(s) and cross-functional study team(s) through expert knowledge and effective use of the systems, tools and processes available with a focus on a complete and accurate Trial Master File (TMF) delivery. Supports Project Support Specialist (PSS) in setting up and archiving eTMF(s). THIS IS A HYBRID ROLE: WE EXPECT THE SUCCESSFUL CANDIDATE TO WORK IN THE OFFICE 2-3 DAYS PER WEEK.
Specific Duties:
- Administrative Support to the Project team: Support clinical trial teams in the planning, initiation, execution, and close-out of studies in compliance with ICH-GCP, SOPs, and regulatory requirements.
- TMF Management: Maintain and update the Trial Master File (TMF/eTMF) to ensure inspection-readiness at all times.
- CPTMS Management: Manage and support the Clinical Trial Management System (CTMS), ensuring accurate and timely data entry, updates, and reporting.
- Project Tracking: Coordinate and track study documents, contracts, and essential trial correspondence.
- Assist with the preparation and review of study-related materials, including site binders, tracking logs, and meeting minutes.
- Coordination of study specific training in the Learning Management System (LMS).
- Support preparation for audits and inspections, including document retrieval and QC checks.
- Provide mentorship and guidance to junior Clinical Trial Assistants or administrative staff.
Person Specification:
- Exceptional interpersonal skills to work with sites, TMC employees and other associates.
- First-class administrative and organisational skills.
- Proactive approach to work, demonstrating initiative and reliability.
- High standard of written and spoken English, with a keen eye for detail.
- Outstanding work ethic and commitment to meeting timelines without compromising quality.
Education and Qualifications:
- Required: Either relevant work experience or High School Diploma (or equivalent).
- Fluent in English to business level.
- Desirable: Degree-level qualification in a life-science discipline or equivalent and/or a Qualification in clinical research.
Specific Knowledge, Experience and Technical Skills:
- 3-5 years of administrative support experience or equivalent combination of education, training and experience.
- Minimum 2 years clinical research experience.
- Good working knowledge of GCP- E6 R3.
- Good knowledge of clinical trial documentation.
- Able to use clinical trial management systems.
- Basic understanding of the clinical trial process and lifecycle.
- Computer literacy: e.g., Microsoft Word, Excel, PowerPoint, Outlook.
Senior Clinical Trial Administrator in Hartley Wintney employer: TMC Pharma Services Ltd
TMC is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for a Senior Clinical Trial Administrator to thrive. With a strong emphasis on employee growth, TMC offers comprehensive training and mentorship opportunities, ensuring that team members are well-equipped to excel in their roles. The hybrid work model allows for flexibility while maintaining a supportive office environment, making TMC a rewarding choice for those seeking meaningful contributions in the clinical research field.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Trial Administrator in Hartley Wintney
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We think you need these skills to ace Senior Clinical Trial Administrator in Hartley Wintney
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at TMC Pharma Services Ltd!
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