Clinical Research Consultant
Russell Oakley is currently recruiting for a Clinical Research Consultant or Clinical Project Manager to join our client at their site based in Cambridgeshire on a permanent basis.
The main purpose of the role will be:
The Clinical Research Consultant has primary responsibility for the delivery of Clinical Projects and will be the main point of liaison within the company for the client and associated third-part vendors. They also work with other staff to develop and promote the business, maintaining an awareness of, and providing feedback on, client, industry and regulatory development to input into the strategic development of the company.
Duties include, but are not limited to: Clinical Consultancy, assisting Client in taking their products to the clinic; Ensuring that study deliverables are achieved in a timely manner to agreed quality standards and that all statutory reporting requirements are performed in line with the local regulatory and ethics requirements; Review of Sponsor contracts on a regular basis; ensuring that they remain current and in-scope, instigating the change order process where necessary; Monitoring and review of project invoices; Management of study monitoring team including participation in monitoring of study sites, as appropriate; Management of study documentation including: set-up and maintenance of the Trial Master File, study-specific forms, Investigator Site files, Ethics Committee submissions and archiving processes; Organisation and planning of study-related meetings; ensure written records are kept including all key decisions; Medical writing including CSRs and QC of final draft documentation; Preparation and review of draft study documents and reports; Management of the reporting of adverse events, as appropriate; Assisting with development of the Clinical Group's infrastructure including review and preparation of Standard Operating Procedures; Line management; Developing and maintain effective working relationships with internal and external clients, third parties and suppliers, as well as maintaining high levels of customer service to meet client expectations at all times.
Desirable qualifications and experience: A Clinical Research Professional with a sound understanding of the clinical research process for pharmaceutical/healthcare products. With extensive experience from working in a pharmaceutical/healthcare product development environment, including direct experience as a Project Manager. Competent IT skills including the use of MS Office applications in Word, Excel, Powerpoint and outlook.
For more information or to apply for this position, please contact Russell Oakley on 01246 457733 or email firstname.lastname@example.org Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30372 in all correspondence.