Senior CTA

A Senior CTA is required for an initial 12 month contract with a global pharmaceutical company with offices in Central London. 

Working 3 days per week in London, the successful candidate will be responsible for maintaining accurate and/or complete Trial Master Files (TMF) and Sponsor Study Files (OSF) according to European and US regulations as well as corporate standard operating procedures (SOPs). The Senior CTA will also support the Clinical Operations Manager in the coordination of logistical aspects of assigned clinical trials. They act as a pivotal point of contact & support for the clinical trial team.

The Senior CTA may also provide oversight and support to other CTA(s) and is expected to take a lead role in ensuring that all trials are adequately documented, and that SOPs reflect current and best practice.

Principal responsibilities will include:

• Responsibility for ensuring that the OSF and/or the TMF (to include electronic TMFs) is complete and accurate on an ongoing basis and ready for archiving according to timelines.
• Performing/overseeing periodic QC of OSFs and/or TMFs to 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
• Provide supervisory oversight and support to other CTA(s) as appropriate and take a lead role in ensuring that all trials are adequately documented and that SOPs reflect current and best practice.
• Liaison with the Clinical Archivist to ensure timely coordination of archiving study documentation.
• May also act as Clinical Archivist or as back-up Archivist.

Requirements of the role:

• Significant 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 multiple phase experience).
• In depth 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, a self-starter.
• A can-do attitude with a willingness to get actively involved. 
• Experience working in a team environment under time and resource pressures.
• Able to organise and oversee multiple on-going tasks, and understand the differing priorities

For additional information and a confidential discussion, please apply now with an updated CV.