Oversee and execute core duties encompassing strategic planning, project management, and cross-functional collaboration to drive organizational objectives. Develop and implement policies, procedures, and performance metrics to ensure operational efficiency and compliance with industry standards. Lead initiatives to enhance productivity, optimize resource allocation, and foster innovation within the team. Serve as a liaison between senior leadership and departmental teams to align goals and facilitate seamless communication. Monitor progress, analyze key performance indicators, and provide actionable insights to senior management to support data-driven decision-making.
Document management responsibilities involve the meticulous oversight of critical trial documentation, including, but not limited to, the Trial Master File (TMF).
Regulatory compliance support involves ensuring that studies adhere to established guidelines, including Good Clinical Practice (GCP), standard operating procedures (SOPs), and relevant regulatory mandates.
Supporting audit and inspection readiness involves facilitating comprehensive preparation for regulatory audits or inspections conducted by authorities such as the MHRA and FDA.
Monitor compliance metrics, identify deviations, and track quality issues through consistent monitoring and detailed reporting.
Process improvement involves identifying inefficiencies and addressing gaps to enhance the effectiveness of compliance processes.
What We’re Looking For
Compliance experience in clinical trials is a mandatory prerequisite for this role.
The ideal applicant must possess strong proficiency in English, both written and verbal.
Proficiency in relevant clinical research regulatory standards, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH), is essential.
A bachelor’s degree in life sciences or relevant professional experience in the field is required.
This position does not qualify for visa sponsorship, and candidates must possess a valid right to work in their country of residence.
Qualifications
BA/BSc/HND
