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