Senior Clinical Trials Associate
Steve Lord at CK Clinical is recruiting for a Senior Clinical Trials Associate to join a leading, Global Pharmaceutical company, on a full time, 12 month contract basis, to be based in Central London.
The primary purpose of the Senior Clinical Trials Associate (sCTA) is to maintain 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 sCTA will also support the Clinical Operations Manager (COM) 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 sCTA is also expected to provide supervisory oversight and support to other CTA(s) and take a lead role in ensuring that all trials are adequately documented and that SOPs reflect current and best practice.
- 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.
- Maintaining and updating any electronic study folders to ensure eFiles reflect any paper TMF/OSF and vice versa.
- Providing supervisory oversight and support to other CTA(s) 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. 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.
- Liaising with Regulatory Affairs to ensure linkage with regulatory approvals.
- Creating and maintaining study contact lists and relevant information databases for study team.
- Facilitating and tracking any study payments following the internal approval process.
- Facilitating the obtaining and maintenance of study insurance.
- Contributing to the development and maintenance of company SOPs and ensuring contribution to process improvement within the clinical operations team and the company in general.
- Ensuring learning and knowledge transfer during and at the completion of the clinical study(s).
- Any other duties as required by the Head of Clinical Operations, Head of EU/US Drug Development and Managing Director and assisting the EU/US Drug Development Division in activities other than those specified above.
- Some manual lifting is required within this job role e.g. moving files, archiving files, lifting boxes, carrying items from loading bay and around the office.
As a Senior Clinical Trials Associate, you will have the following qualifications, skills and experience:
- 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 desirable. 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.
- Proven ability for working independently with minimal supervision.
- 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.
- Excellent communication skills (verbal and written) and time management skills.
- Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
For more information or to apply for this position please contact Steve Lord on 01246 457733 or email firstname.lastname@example.org. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. Entitlement to work in the EEA is essential. Please quote reference 47061 in all correspondence.