Senior Clinical Trial Associate

Hobson Prior are looking for a Senior Clinical Trial Administrator to join a fantastic pharmaceutical organisation on a permanent basis located in Central London. Our client is focused on fighting disease and pain.

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

Key Responsibilities:

• 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 at OPUK 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) and take a lead role in ensuring that all OPUK 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. Act as a back-up Clinical Archivist.
• 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. Liaise with Regulatory Affairs to ensure linkage with regulatory approvals.
• Printing, distributing and tracking of any study specific documents internally and to any SPs (e.g. Protocols, Investigator Brochures).
• Any other assigned duties.

Key Skills:

• Proven ability for working independently with minimal supervision.
• Excellent communication skills (verbal and written) and time management skills.
• Proficient computer skills in Word, Excel, PowerPoint, email and Internet.

Requirements:

• A University degree or equivalent in health sciences, nursing or pharmacy or related field would be preferred.
• Substantial demonstrable experience of working as a CTA and/or Document Manager in Clinical Research or the Pharmaceutical Industry.
• Prior demonstrable supervisory experience and mentoring junior staff.
• A can-do attitude with a willingness to get actively involved. Experience working in a team environment under time and resource pressures.
• Must be diplomatic and tactful in liaising with staff and management.
• Must be meticulous and methodical and detailed oriented.
• 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.
• Able to interact effectively at all levels within the organisation, as well as with external partners and clients.

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.