Oncology Local Study Lead — Clinical Trials

ThermoFisher Scientific; Chile; Remote; CLP 40.000.000 - 60.000.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific is seeking a Local Study Associate Director to lead country-level study teams and ensure timely, quality delivery of clinical study components. This role oversees site identification, qualification, initiation, monitoring, and archival of essential documents, while coordinating regulatory submissions and local budgets.

The position requires strong leadership of CRA/CSA teams, expert ICH-GCP knowledge, and collaboration with Regulatory Affairs, Medical Affairs and SMM to

Qualifikationen

• Leads Local Study Team(s) to deliver study components.
• Strong knowledge of ICH-GCP and local regulations.
• Experience in site qualification visits and monitoring.
• Coordinates regulatory submissions and EC/IRB processes.
• Manages country-level study budgets and financial reporting.

Aufgaben

• Leads Local Study Team consisting of CRA(s), CSA(s) for assigned studies.
• Ensures timely submission of documents to EC/IRB and Regulatory Authority.
• Oversees study setup, monitoring, and closure in line with SOPs.
• Maintains study documents and eTMF for inspections readiness.
• Plans local Investigator meetings and recruitment strategies.
• Collaborates with Medical Affairs and SMM teams on initiatives.

Kenntnisse

Team Leadership

ICH-GCP Knowledge

Site Monitoring

Regulatory Coordination

Budgeting

Jobbeschreibung

Thermo Fisher Scientific is seeking a Local Study Associate Director to lead country-level study teams and ensure timely, quality delivery of clinical study components. This role oversees site identification, qualification, initiation, monitoring, and archival of essential documents, while coordinating regulatory submissions and local budgets.

The position requires strong leadership of CRA/CSA teams, expert ICH-GCP knowledge, and collaboration with Regulatory Affairs, Medical Affairs and SMM to