Protocol Development Specialist - (Healthcare - 2 year FTC - Renewable)

Contract Period : 2 year Fixed Term Contract - Renewable

Responsibilities :

• Develop and maintain Standard Operating Procedures relevant to the portfolio
• Develop protocol templates for early phase clinical studies, Phase I trials, Phase I first in Human studies to Phase III trials
• Develop standardized VM-CTU case report forms in conjunction with the Trial Data Manager, Statisticians, Clinical, Laboratory Investigators and Behavioural Scientists (where applicable)
• Work with Principal Investigators, Regulatory Manager, Trial Study Coordinators & Science Support Leads to obtain necessary information to complete trial protocols in advance of regulatory and funder submission dates
• Lead protocol writing meetings with the VM-CTU Principal Investigator, Individual Trial PIs and others as needed
• Manage the rapid update of protocols where needed and work with the Regulatory Manager to create and distribute letters of amendment & clarification memos
• Update the Investigators Brochure (for all investigational products) routinely as new data becomes available with the Sponsor and ensure coordination with Regulatory Manager
• At the end of each trial, draft the Clinical Study Report & work with the Statisticians, Investigators and Data Management to finalize
• Support the trial Principal Investigators with medical writing and presentation preparation

Minimum Requirements :

TO APPLY :