Senior Study Start-up Specialist - West London
A premier multinational contract research organisation, providing consultation in the biopharmaceutical and medical device sector, have a vacancy for a Study Start Up Specialist. The Initiation Clinical Site Manager (iCSM) or Study Start Up Specialist specialises in Pre SIV activities will be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCSM can also support protocol amendments if applicable. This role is office based from our UK Head Office situated in Uxbridge.
- Acting as the company's direct point of contact with assigned clinical sites and being accountable for quality and delivery during the start-up phase.
- Building relationships with investigators and site staff.
- Conducting, driving, and managing country specific feasibility, and/or site pre-qualification and qualification activities.
- Preparing, negotiating, and facilitating of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conducting remote Qualification Visits (QVs).
- Generating visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Developing strategy to configure, distribute and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customising, reviewing and negotiating as needed, country/site specific Informed Consent Forms (ICF), translating (within parameters of country/regulatory/client requirements), and customising negotiating any amendments.
- Preparing and submitting IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, and determining appropriate follow up until receipt of final approval.
- Submitting all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecasting, developing, managing and revising plans and strategies for IRB/IEC/approval, site activation, patient recruitment, and retention.
Skills and Requirements:
- At least a BS/BA in a biological science, pharmacy, or other health related discipline. Alternatively, a nursing qualification or other equivalent experience is acceptable.
- Extensive Site Management experience, or equivalent Senior CRA or monitoring experience in clinical research, with an understanding of clinical trials, methodology and terminology.
- Demonstrably strong previous onsite clinical monitoring experience is essential in the capacity of a Sr CPA.
- Demonstrably strong interpersonal, written, and verbal communication skills within a matrixed team.
- Ability to work successfully in a 'virtual' team environment.
- Demonstrable consulting skills.
- Advanced presentation skills.
- Able to accommodate travel time requirements, according to the task allocation/phase of the study assigned.
- A valid driver's licence.
- Client focused approach to work; flexible attitude with respect to work assignments and new learning.
- Able to work proactively and independently or in a team environment.
- Good organisational and time management skills.
- Able to organise competing priorities logically and review outstanding contractual risk and issues.
- Able to effectively use automated systems and computerised applications, such as a Clinical Trial Management System (CTMS), Electronic Document Management Systems (EDMS) Microsoft Outlook, Excel, Word, etc.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 752 0314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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