Oversee and execute a range of critical duties encompassing strategic planning, operational management, and cross-functional collaboration to drive organizational success. Develop and implement policies, procedures, and performance metrics to ensure efficiency, compliance, and continuous improvement. Lead and mentor teams, fostering a culture of accountability, innovation, and high performance. Partner with senior leadership to align departmental objectives with broader company goals, ensuring seamless integration and execution. Analyze key performance indicators, market trends, and competitive insights to inform data-driven decision-making and strategic initiatives. Manage budgets, resources, and stakeholder relationships to optimize productivity and achieve fiscal targets. Ensure adherence to industry regulations, safety standards, and ethical guidelines while promoting a safe and inclusive work environment.
Document management involves the systematic administration and coordination of critical trial documentation, such as the Trial Master File (TMF). This role requires meticulous oversight to ensure proper organization, accessibility, and compliance with regulatory standards throughout the trial lifecycle.
Providing regulatory compliance assistance, this role ensures adherence to critical guidelines including Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all pertinent regulatory mandates throughout clinical studies.
Ensuring audit and inspection readiness involves facilitating comprehensive preparations for regulatory audits or inspections conducted by bodies such as the MHRA or FDA.
Monitoring and documenting compliance metrics, deviations, and quality-related concerns are essential responsibilities of this role. Regular tracking and accurate reporting of these elements ensure adherence to established standards and prompt identification of potential issues.
Process improvement involves systematically identifying inefficiencies and addressing gaps to enhance the effectiveness of compliance-related processes. This role focuses on analyzing existing workflows, pinpointing areas of non-compliance, and implementing strategic improvements to ensure adherence to regulatory standards and organizational policies.
What We’re Looking For
Compliance experience in the context of clinical trials is a prerequisite for this position.
Fluency in English is a mandatory requirement for applicants.
Proficiency in relevant clinical research regulatory standards, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, is required.
A Bachelor’s degree in life sciences or comparable professional experience within the industry is required.
Please be advised that this position does not qualify for visa sponsorship, and candidates are required to possess a valid right to work in their country of residence.
Qualifications
BA/BSc/HND
