Oversee and execute a comprehensive range of duties aligned with the role’s core objectives, ensuring operational excellence and adherence to organizational standards. This includes managing daily tasks with precision, collaborating with cross-functional teams to achieve strategic goals, and maintaining meticulous records to support data-driven decision-making. Additionally, the position requires monitoring performance metrics, identifying areas for improvement, and implementing corrective actions to enhance efficiency and productivity. Strong communication skills are essential to convey complex information clearly, while adaptability and problem-solving abilities enable effective navigation of challenges. Must demonstrate proficiency in relevant tools and systems, a commitment to continuous learning, and a proactive approach to meeting deadlines and exceeding expectations.
Oversee documentation by expertly managing and systematically organizing critical trial-related files, including the Trial Master File (TMF).
Provide regulatory compliance support by ensuring that studies adhere to established guidelines, including Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all relevant regulatory requirements.
Supporting audit and inspection readiness involves facilitating comprehensive preparations for regulatory audits or inspections conducted by authoritative bodies, such as the MHRA or FDA.
Tracking and reporting duties include overseeing compliance metrics, identifying deviations, and addressing quality issues to ensure adherence to established standards and protocols.
Process improvement involves pinpointing inefficiencies and enhancing compliance-related procedures to ensure optimal performance and adherence to regulatory standards.
What We’re Looking For
Compliance experience in clinical trials is a prerequisite for this role.
Fluency in English is required for this position.
Applicants must possess a thorough understanding of key clinical research regulatory standards, including Good Clinical Practice (GCP) and the guidelines established by the International Conference on Harmonization (ICH).
Holders of a degree in life sciences or individuals possessing equivalent professional experience in the field will be considered for this position.
This position does not qualify for visa sponsorship, and candidates must possess valid work authorization in the country where they reside.
Qualifications
BA/BSc/HND
