An experienced CTA is required to join a global pharmaceutical company in London on a contract basis. This contract will sit inside IR35. There is a requirement to work in the office in Central London at least 3 days per week.
Main responsibilities of the Clinical Trials Associate will be to maintain accurate and/or complete Trial Master Files and Sponsor Study Files according to European and US regulations as well as corporate SOPs. The CTA will also support the Clinical Operations Manager in the coordination of logistical aspects of assigned clinical trials.
What you will be doing:
- Ensuring that the Sponsor Study Files (OSFs) and/or the TMF/eTMF is complete and accurate on an ongoing basis and ready for archiving according to timelines.
- Performing/overseeing periodic QC of OSFs and/or TMFs ensure completeness and accuracy
- Performing QC of any TMF maintained by Service Providers (SPs) during and at the end of a study as well as an evaluation of the SPs TMF processes before study initiation.
- Maintaining and updating any electronic study folders to ensure eFiles reflect any paper TMF/OSF and vice versa Arranging and participating in the organisation of Investigator Meetings & Study Team Meetings (internal and external), preparing agendas, and taking (where appropriate) and distributing minutes as required.
- Co-ordinating any study document reviews where required Assisting with the Ethics submissions; keep a track of submissions & approvals for the study.
- Creating and maintaining study contact lists and relevant information databases for study team
- Sending out Study Newsletters / Study Correspondence to all participating SPs/sites on an ongoing basis.
- Facilitating and tracking any study payments following the internal approval process.
- Contributing to the development and maintenance of company SOPs and ensuring contribution to process improvement within the clinical operations team.
What you can bring to the role:
- Substantial demonstrable experience of working as a CTA and/or Document Manager in Clinical Research or the Pharmaceutical Industry.
- University degree or equivalent in health sciences, nursing or pharmacy or related field would be preferred
- Good knowledge of the Pharmaceutical Industry/Clinical trial process (ideally early phase).
- Knowledge, experience, and implementation of eTMFs.
- An aptitude and experience towards bringing in new electronic systems is important.
- Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
- Results driven attitude and good sense of urgency.
- Able to anticipate and proactively address issues and demands Able to interact effectively at all levels within the organisation, as well as with external partners and clients.
- Proven ability for working independently with minimal supervision.
What you get in return:
- The opportunity to work with a global pharma who are going through a phase of growth and development.
- The chance to work on EU/global clinical trials across multiple therapeutic areas.
- Competitive daily rates.
What to do next:
- Please apply now with an updated CV in order to arrange a confidential discussion.