Engela Nortje

Clinical research and operations professional with experience supporting Phase I–III clinical trials, including 9 Phase III studies and oncology trials covering skin cancer, breast cancer, lung cancer, and melanoma. Experienced in clinical trial documentation, GCP/ALCOA quality requirements, source-document QC, laboratory sample management, eCRF data maintenance, Sponsor/CRO monitoring visits, audit and regulatory-inspection preparation. Brings additional business and management experience across financial administration, accounting, human resources, and operational management.

Financial and Operation Manager - Excellentis Clinical Trial Consultants

(2019-11)

Managed a team of 45 employees, providing leadership, operational oversight, staff coordination, and performance management. Held 40% ownership in the company, contributing to strategic decision-making, business operations, and financial oversight.

• Coordination/support of Phase I–III clinical trials
• Oncology and lupus studies
• Prepare for Sponsor/CRO monitoring visits, audits, and regulatory inspections
• Audit and regulatory-inspection preparation
• ISF management and quality control
• Source-document QC
• GCP and ALCOA principles
• Essential-document reconciliation
• Sample processing, storage and shipment
• IATA-compliant shipment
• Laboratory kit/supply tracking
• Equipment calibration and fitness-for-use
• eCRF data entry and maintenance
• Query resolution
• Source-data quality checks
• Clinical-trial invoice preparation, review and reconciliation
• Study payment and budget tracking
• Monitoring and follow-up of site expenses and outstanding payments
• Administrative and operational system implementation
• Experience in debtors, creditors, and bookkeeping support

Finance for study invoices. Part-time consultant and administrative assistant - Excellentis Clinical Trial Consultants

(2019-06 - 2019-11)

• Preparation, review, and reconciliation of invoices

Practice Manager - De Necker Dental Practice - George

(2015-01 - 2019-11)

Practice Manager - De Necker Dental Practice - Pietermaritzburg

(2011-01 - 2014-12)

Supported the establishment of a new practice and oversaw 3 practices. Managed a team of 45 employees across practice operations. Spread across the three practices.

• Recruited, trained, managed performance, handled disciplinary matters, maintained personnel records
• Supplier management
• Operational improvements
• Procedures

Receptionist & Creditor Clerk - De Necker Dental Practice

(2008-01 - 2011-12)

Chairside Dental Assistant - De Necker Dental Practice

(2003-01 - 2008-12)

Chairside Assistant / Administration / Creditor Clerk - Dr vd Walt Private Practice

(2000-01 - 2003-12)

Receptionist / Food & Beverage Manager - Wagon Wheel Protea Lodge

(1996-01 - 2000-12)

Pharmacy Assistant - Pharmacy, Beaufort West

(1994-01 - 1995-12)

Basic Course - Client Service - Western Cape Tourism (2002-01 - 2002-12)

Course - Infection Control and Oral Hygiene - Unique Dental (2004-01 - 2004-12)

Dental Assistant - Dental Assistance - Board of Examinations, HPCSA (2005-01 - 2005-12)

Short Course - Managing Discipline in Workplace - K&S (2009-01 - 2009-12)

Course - MS Word, MS Excel, MS Word - Leanco Business Services & Training Center (2010-01 - 2010-12)

Diploma - Hotel Management - INTEC College Cape Town (2014-01 - 2014-12)