Clinical Trial Manager, Brain and Mind Institute

Job Summary

The Clinical Trial Manager (CTM) plays a pivotal role by overseeing the planning, implementation, and multi-site operations management of clinical trials across multiple sites. With a focus on ensuring adherence to regulatory requirements and ethical standards, the CTM will be fully responsible for managing timelines and overseeing all project deliverables across four sites in Kenya and Nigeria, for the Multi-National Implementation of Multimodal Strategies to promote Healthy Brain Ageing in Sub-Saharan Africa (The AFRICA-FINGERS) project, including ensuring that the execution of the clinical and non-clinical aspects of the trial are in line with study sponsor and research governance expectations.

With oversight from BMI’s Principal Investigators (PIs), the postholder will further provide clinical project management expertise for the optimal set-up of other clinical studies within the Institute, including protocol development, obtaining regulatory approvals, recruiting participants, managing data collection and analysis, and ensuring compliance with all relevant guidelines and protocols throughout the trial lifecycle. By efficiently managing clinical trials, the CTM helps advance research initiatives aimed at understanding and treating neurological disorders, ultimately contributing to the institute's overarching objectives in the field of brain health.

Responsibilities

• Develop and implement clinical trial protocols in collaboration with the research team and Principal Investigator(s).
• Coordinate with regulatory agencies to obtain necessary approvals for clinical trials and ensure compliance with all applicable regulations and guidelines.
• Manage the development of contractual agreements and other regulatory files including data use, data transfer and material transfer agreements.
• Coordinate with research partners and stakeholders to establish clinical trial sites, ensuring compliance with regulatory requirements and ethical standards.
• Develop and implement participant recruitment strategies in collaboration with the study team and external partners.
• Track and analyse recruitment data to assess the effectiveness of different strategies and adjust as needed.
• Conduct site visits to monitor the progress of the trial and assess compliance with protocol and regulatory requirements.
• Monitor adverse events and serious adverse events reporting, ensuring timely and accurate documentation and reporting to regulatory authorities.
• Monitor data quality and integrity throughout the trial, identifying and addressing any discrepancies or issues.
• Collaborate with biostatisticians and statistical programmers to ensure accurate and timely analysis of trial data.
• Develop and execute a study close-out plan in collaboration with the study team, sponsors, and regulatory authorities.
• Support in manuscript development for peer-reviewed journals and present findings at conferences, develop policy briefs and disseminate research findings to relevant stakeholders.

Requirements

•  A master’s degree in a scientific or related field is required; an advanced degree such as a PhD is highly preferred
• Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations as well as Declaration of Helsinki and relevant country-specific regulations is required.
• Minimum 5 years relevant experience in clinical trial operations, including 3 years in clinical trial management.
• Experience leading multi-disciplinary clinical trial teams, effectively delivering clinical trials at high quality, on time and within budget is required.
• Familiarity with Alzheimer’s disease and related dementias (ADRD) and/or global health and managing trials in Sub-Saharan Africa is highly desirable.
• Ability to mentor other clinical operations staff is required.
• Experience with electronic document management systems as well as electronic data capture systems is required.