Experience

ERGOMED

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Study Start Up and Regulatory Lead

  • Oct 2020 - Present

  Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance. Collaborate with major functional area leads to identify and evaluate fundamental issues pertaining to Site Start-Up and project regulatory pathway. Collaboration with business leads for business development, contracts and proposals development, project management, and clinical management in achieving project goals. Ensuring that individual project targets and client needs are met. Provides oversight of all project SSU deliverables which encompasses all activities from Site selection through Site activation ready. Coordination of regulatory ethics submissions for all projects within the portfolio in line with project timelines and strategic delivery plan. Accountable for the development, monitoring, implementation and execution of the site activation delivery plan in relation to contractual timelines for all projects within the given portfolio. Review of the project SSU budget with the functional leads and PM against project milestones and budget to ensure project profitability. Taking corrective measures where necessary to keep projects in line with budget and gross profit expectations. Oversees collation, quality review, and submission of country-specific applications. Accountable for the timely follow-up for Ethics Committee/Competent Authority enquiries or objections. Meets or exceeds the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, solves or escalates the problem quickly. Accountable for the oversight of negotiation and execution of clinical trial agreements and budgets in accordance with agreed timelines. Participates in new business development activities including participation at client presentations.