London, England, United KingdomOn-site CRA responsible for site management of all active and historical studies. - Provided oversight of the Site Compliance Specialist team, supporting daily tasks such as ISF and source data maintenance, EDC query resolution, and study vendor management.
-Led the collation and closure of issues from past CRA visits and monitoring letters.
- Collaborated cross-functionally with the clinical...
Various clinical monitoring, project and stakeholder management activities, including study start-up (writing and adapting ICFs & other supporting documents, ethics and regulatory submissions, budget & contract negotiations), feasibility, SIVs, IMVs and COVs. Highly proficient with IRAS and CPMS/iCT submissions.
United KingdomExperienced Clinical Research Consultant supporting end-to-end delivery of commercial clinical trials for leading biopharmaceutical clients, including Syneos Health, Panthera Bio-Partners, Rho, and Allucent. Skilled in onsite and remote monitoring, regulatory submissions, project management, feasibility, and contract negotiations. Leads initiatives to enhance trial performance, patient enrolm...