Clinical Trial Associate - eTMF

Hobson Prior are looking a Clinical Trial Associate to join a fast-paced biopharmaceutical organisation who are creating ground-breaking products that have never been made before. This position will be 3 days per week in the Hammersmith office and 2 days working from home.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Clinical Operations Director.
• Very Knowledgeable with applicable ICH GCP, and DIA TMF requirements.
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• Support the Clinical Operations teams with ongoing conduct of studies.
• Ability to develop or use existing tracking tools.
• Proficiency in office suite and particularly Microsoft Excel and PowerPoint.
• Familiar with various roles within clinical operations, such as a CRA role and PM.
• Assist project teams with study specific documentation and guidelines as appropriate.
• Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• To assist project teams with trial progress tracking by updating the Clinical Trial Management systems. Asist in co-ordination of Investigator payments, if applicable.
• Contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc. when requested).
• Maintain the Training Matrix and training forms.
• Submit system requests for the Clinical Operations teams and vendor representatives when applicable.
• Conduct initial submission QC in Veeva Vault and assist in completing quarterly QC of the eTMF.
• Any other duties assigned.

Key Skills:

• Good organizational skills, ability to manage multiple tasks.
• Meticulous attention to detail.
• Excellent oral and written communication, organizational and planning skills.

Requirements:

• At least 2-3 years' experience as a CTA in either pharmaceutical/biotech.
• Experience in clinical study execution.
• Experience in cell therapy.
• Experience in solid tumor studies.
• Experience in managing several studies/programs.
• Expertise in Veeva.
• Proficiency with Microsoft Office Suite and DocuSign.
• Experience in performing inspection readiness activities.
• Willingness to travel as needed
• Bachelor's degree (BSc, BA or RN equivalent) in a biological or science-related field is essential.
• A valid driving licence.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.