Operations Executive
Marketing Pros
TypeScript
Job Level
JuniorMid-Level
Tech Stack
TypeScript
About the role
- Planning, management, and oversight of clinical study execution in accordance with global program strategy, through leadership of the Local Study Team (LST).
- Support country-level operational planning and site selection within assigned country/ies.
- Contributes and develops study-specific materials – e.g., monitoring plan, study specific training documents.
- Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda-driven meetings.
- Communicates country status (timelines and deliverables) to key stakeholders (GCM, Program Managers, CST or TMT, DOM) with oversight as required and ensures updates to relevant systems.
- Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/ - ies.
- Contributes to study-level forecast for investigational product, support study-level accountability and reconciliation across countries, management of E LE (enrolment long-range estimates) process.
- Monitors execution of the clinical study against timelines, deliverables, and budget for that country.
- Translates global startup requirements into local country targets.
- Monitors country enrolment and retention and act on deviations from plan.
- Identify barriers to enrolment and support recruitment and retention strategic solutions.
- Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
- Monitors and reviews country and study trends. Reviews Monitoring Visit Reports.
- Identifies and facilitates resolution of cross-functional study-specific issues.
- Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
- Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
- Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships.
Requirements
- Doctorate degree OR Master's degree & 3 years of directly related experience
- Bachelor's degree & 5 years of directly related experience
- Associate's degree & 10 years of directly related experience
- Preferred Qualifications: BA/BS/BSc
- Minimum 2-3 years’ experience of leading local/regional trials
