Strategic Clinical Trial Lead (Cross-Functional)

Total Trials Company; Centurion; Vor Ort; ZAR 900.000 - 1.300.000; Vollzeit

Zusammenfassung

Total Trials Company in South Africa is seeking a Clinical Trial Manager to lead day-to-day clinical operations across sites and vendors, ensuring on-time, high-quality delivery per GCP. You will collaborate with cross-functional teams and manage risk, timelines, and communication with sponsors and sites.

The role requires a Bachelor’s degree, 5+ years monitoring experience, CRO background, knowledge of ICH GCP, and proficiency with EDC and CTMS. Travel 20–25% domestically and internationally.

Qualifikationen

• Bachelor’s degree or equivalent; nursing/life science preferred.
• 2+ years CRO experience managing trials; 5+ years monitoring preferred.
• Expertise in ICH GCP and regulatory guidelines.
• Experience with EDC and CTMS systems required.
• Strong written and verbal communication; meticulous documentation.

Aufgaben

• Oversee quality and clinical operations in line with ICH GCP.
• Coordinate investigator meetings with Project Manager.
• Deliver study documents and materials promptly.
• Generate and maintain the Clinical Monitoring Plan.
• Track trials, Trial Master File, and project status reports.
• Review monitoring visit reports and ensure timelines alignment.
• Mentor clinical staff and manage vendors and sites.
• Monitor data milestones and support sponsor audits.
• Conduct co-monitoring visits as scope allows.
• Identify and escalate risks; drive process improvements.

Kenntnisse

ICH GCP

CRO experience

Monitoring

EDC/CTMS

MS Office

Ausbildung

Bachelor’s degree or international equivalent

Tools

EDC systems

CTMS

MS Office Suite

Jobbeschreibung

Total Trials Company in South Africa is seeking a Clinical Trial Manager to lead day-to-day clinical operations across sites and vendors, ensuring on-time, high-quality delivery per GCP. You will collaborate with cross-functional teams and manage risk, timelines, and communication with sponsors and sites.

The role requires a Bachelor’s degree, 5+ years monitoring experience, CRO background, knowledge of ICH GCP, and proficiency with EDC and CTMS. Travel 20–25% domestically and internationally.