Hobson Prior are looking for a CTA to join a biotechnical organisation on a permanent basis located in Hammersmith with hybrid working available. Our client is focused on producing ground-breaking cancer immunotherapies that are aimed to target clonal neoantigens.

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

Key Responsibilities:

• For this role, you will be responsible for providing general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Clinical Operations Director(s).
• You will be assisting the Clinical Operations teams in completion of all essential tasks to meet departmental and project goals.
• Support the Clinical Operations teams with ongoing conduct of studies.
• Very Knowledgeable with applicable ICH GCP, and Veeva Vault eTMF requirements.
• Develop or use existing tracking tools.
• Familiar with various roles within Clinical Operations, such as a CRA role and CPM.
• Assist Project Teams with study specific documentation and guidelines as appropriate.
• Set up, organise and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Facilitate in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• Aid Project Teams with trial progress tracking by updating the Clinical Trial Management systems, which include study metric trackers and reports.
• Accountable for serving in co-ordination and tracking of Investigator sites and Vendor payments.
• Communicate with clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc. when requested).
• Maintain the Training Matrix and training forms.
• You will submit system requests for the Clinical Operations teams and Vendor Representatives when applicable e.g. for the eCRF, eTMF.
• Handle documentation QC review in Veeva Vault eTMF and support in completing quarterly QC of the eTMF.
• Provide support for the eTMF Manager in the upkeep of the eTMF; this may include configuration/process updates.
• Contribute in aiding with the tracking and delivery of safety reports.
• Co-ordinate document translation, if required.
• Assist the Project Manager and Project Team with Investigator Meeting coordination, activities in preparation and generate meeting agenda and minutes.
• Assist in the production of slides, etc., as needed for project, departmental, and/or business development presentations.
• Other duties may be assigned as required.

Key Skills:

• Good organisational skills, ability to manage multiple tasks and meticulous attention to detail.
• Outstanding oral and written communication, organisational and planning skills.
• Adapt effortlessly to a fast-paced environment.

Requirements:

• At least 2-3 years of experience as a CTA in either pharmaceutical/biotech.
• Familiarity in clinical study execution.
• Experience in cell therapy is desirable but not essential for the role.
• Competent in solid tumor/oncology studies would be preferable.
• Knowledge in managing several studies/programs across global sites.
• Proficiency in multiple Veeva System platforms, particularly the eTMF.
• Capability with using Microsoft Office Suite, DocuSign and Adobe Acrobat.
• Experience in performing inspection readiness activities.
• Ability to travel will be required for this role.
• Attained a valid driving license.

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.