Contract CTA (hybrid)

Proclinical are recruiting for a Contract CTA to join a small biotech. This role is on a contract basis with the option to go permanent and is located in London.

Responsibilities:

• Serve as a main point of contact for the clinical team for allocated project discussions, correspondence, and affiliated documentation.
• Partake in the generation of presentations as required for projects, divisional, sponsor and/or business development requirements.
• Assist both CRA's and any others with preparing, managing, and delivering clinical trial supplied and keep track of information.
• You will arrange, enable and offer logistical assistance for the study team, scheduling meetings, delivering agendas, and writing minutes.
• Contribute to study-specific or vendor audits performed by sponsors or regulatory agencies, and reply to audit observations, when needed.
• Offer general support and assistance to the international clinical operations division as well as to CPM(s).
• Support the clinical operations teams in accomplishing all necessary tasks to meet divisional and project objectives.
• Lead project teams with trial progress tracking by updating the clinical trial management systems.
• Responsible for submitting system requests for the clinical operations teams and vendor representatives when suitable.
• Perform initial proposal QC in Veeva Vault and support in accomplishing quarterly QC of the TMF.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a biological or scientific field and/or a mixture of experience and education.
• Familiarity in a similar role within a biotech, pharmaceutical or CRO as well as in an R&D setting.
• Previously works sponsor-side at a biotech ad/or pharmaceutical organisation.
• Acquaintance with handling electronic TMF, which involves set-up, upkeep, QC/QR and query management, as well as with DIA reference model.
• Expertise on ICH/GCP and suitable guidelines.
• Prior involvement with cell/gene therapy clinical trials as well as hematology/oncology clinical trials.
• Capable of handling various tasks and multifunctional resourced simultaneously with a high attention to detail.
• Able to respond to quick changes in priorities and aggressive timelines.
• Familiarity in conducting inspection promptness actions.
• Computer literacy.
• Acquaintance with eDC systems, such as Rave EDC.
• An organised individual with planning capabilities.
• Communication skills both verbally and in writing.
• Willing to travel for business needs.

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at m.pike@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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