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As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.
What you will be doing:
- Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
- Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents.
- Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
- Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
- Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
- Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
- Responsible for approval of Baseline and Revised Enrolment Plans (Country Level).
- Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
- Translates integral start up requirements into local country targets
- Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
- Identifies and facilitates resolution of cross-functional study-specific issues.
- Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
- Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation).
- Collaborates with local teams to ensure country level stu
Postúlate en Kit Empleo: kitempleo.com.co/empleo/1at9m3