Arcolab is seeking a Lead Researcher with extensive experience in compliance monitoring for clinical trials, bioavailability/bioequivalence (BA/BE) studies, and pharmacovigilance. The ideal candidate will play a crucial role in ensuring quality and regulatory compliance across various operations.
Key Responsibilities:
Quality Management System: Assist in establishing and maintaining the quality management system for clinical trials, BA/BE studies, and pharmacovigilance activities.
Compliance Monitoring: Oversee compliance monitoring to ensure adherence to regulatory guidelines and internal standards within clinical trials and BA/BE organizations.
Process Improvement: Identify and implement process improvements and optimization strategies in pharmacovigilance (PV) and clinical operations (CO).
Regulatory Support: Provide support to the Medical Affairs team in interpreting and applying regulatory guidelines.
Trend Analysis: Track and analyze compliance review trends in PV and CO to identify areas for improvement.
SOP Development: Assist in the preparation and review of standard operating procedures (SOPs) for clinical trials, BA/BE studies, and PV.
Data Review: Conduct reviews of clinical trial data throughout its lifecycle, including paper-based and electronic systems.
Quality Control: Perform quality control reviews of key trial documents such as protocols, informed consent forms, clinical study reports, and investigator brochures.
Pharmacovigilance Oversight: Oversee quality control processes for PV activities, including individual case safety reports (ICSR), aggregate reports, and signal detection.
Audit Preparation: Participate in internal and external audit preparations, inspections, and ensure audit readiness.
Risk Management: Manage risks related to CO and PV functions, implementing risk mitigation strategies as needed.
ISO Compliance: Support the implementation and adherence to ISO 27001 and ISO 27701 standards, ensuring data security and privacy compliance.
