Oversee and execute critical tasks including managing project timelines, coordinating team efforts, and ensuring adherence to company policies and industry standards. Develop and implement strategic initiatives to enhance operational efficiency and drive organizational growth. Conduct regular performance evaluations, provide constructive feedback, and mentor team members to foster professional development. Collaborate with cross-functional departments to align objectives, resolve conflicts, and optimize resource allocation. Monitor key performance indicators to assess progress, identify areas for improvement, and implement corrective measures as needed. Maintain accurate documentation, prepare comprehensive reports, and present findings to senior leadership to support data-driven decision-making.
Document management involves the systematic administration and coordination of critical trial documentation, including the Trial Master File (TMF).
Provide regulatory compliance assistance to ensure studies adhere to established guidelines, including Good Clinical Practice (GCP), standard operating procedures (SOPs), and applicable regulatory requirements.
Facilitate audit and inspection readiness by coordinating and supporting preparations for regulatory audits or inspections conducted by governing bodies such as the MHRA or FDA.
Monitoring and documenting compliance metrics, deviations, and quality concerns constitute key responsibilities in this role.
Process improvement involves identifying inefficiencies within existing compliance frameworks and implementing strategic enhancements to optimize operational effectiveness. The role includes evaluating current procedures, pinpointing discrepancies or bottlenecks, and proposing data-driven solutions to bolster adherence to regulatory standards. Additionally, it requires collaborating with cross-functional teams to ensure seamless integration of improvements while maintaining alignment with organizational policies and industry best practices.
What We’re Looking For
Compliance experience in clinical trials is a prerequisite for this role.
The ideal candidate must possess proficiency in English.
Applicants must possess a comprehensive understanding of clinical research regulatory standards, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, to ensure compliance and adherence to established protocols.
A bachelor’s degree in life sciences or comparable professional experience within the field is required.
Applicants should be aware that this position does not qualify for visa sponsorship, and all candidates must possess a valid right to work within their country of residence.
Qualifications
BA/BSc/HND
