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.
How To Apply
