Clinical Trial Manager, Brain and Mind Institute

Job Summary

The Clinical Trial Manager (CTM) plays a pivotal role within the Brain and Mind Institute (BMI) at Aga Khan University (AKU) by overseeing the planning, implementation, and management of clinical trials. 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 of 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.

Responsibilities

Study set-up

• Develop and implement clinical trial protocols in collaboration with the research team and Principal Investigator(s).
• Manage the day-to-day operations of clinical trials, including budgeting, scheduling, and resource allocation.
• Coordinate with regulatory agencies to obtain necessary approvals for clinical trials and ensure compliance with all applicable regulations and guidelines.

Participant recruitment

• Oversee the recruitment and training of clinical trial staff, including research coordinators, data managers, and other support personnel.
• Develop and implement participant recruitment strategies in collaboration with the study team and external partners.

Supervision

• Regularly review and analyze clinical trial data to ensure accuracy and integrity.
• Conduct site visits to monitor the progress of the trial and assess compliance with protocol and regulatory requirements.
• Verify that informed consent procedures are being followed and documented appropriately.

Partners management

• Facilitate communication and collaboration between internal teams and external partners to ensure smooth execution of clinical trials.
• Manage relationships with external partners to address any issues or challenges that may arise during the execution of clinical trials.

Data management

• Monitor data quality and integrity throughout the trial, identifying and addressing any discrepancies or issues.
• Ensure that data management activities comply with relevant regulations, guidelines, and industry best practices.

Close-out management

• Develop and execute a study close-out plan in collaboration with the study team, sponsors, and regulatory authorities.
• Ensure that all study activities are completed in accordance with the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

Other responsibilities

• In certain study delivery activities, the Manager may be required to serve as backup/cover for other project staff, as the situation demands.
• These initial responsibilities and deliverables may evolve during study initiation, implementation, and close-out; hence other related responsibilities may be assigned.

Requirements

• A master’s degree in a scientific or related field is required; an advanced degree 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.
• Training in clinical trial regulations and guidelines

Relevant Experience

• Minimum 5 years relevant experience in clinical trial operations, including 3 years in clinical trial management.
• Experience in project management, including skills and the ability to deliver on assigned tasks within deadlines is required.
• 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 working collaboratively with people of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of AKU is required.
• Experience with electronic document management systems as well as electronic data capture systems is required.
• Excellent computer skills with software tools needed to fulfill the responsibilities of position is required.

Personal Characteristics

• Strong interpersonal skills and ability to work effectively with outside stakeholders, collaborators, subordinates and functional peer groups at various management levels.
• The ability to work on problems of high complexity and diverse scope using good judgement within defined procedures and policies to determine appropriate action is highly desirable.
• Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required.
• Being detail-orientated, with the ability to work independently on multiple projects/tasks with overlapping schedules and priorities is highly desirable.
• Excellent oral and written communication skills are required. This includes ability to conduct presentations of technical information concerning specific projects and to be an effective trainer