Careers at Aga Khan University Hospital

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.

go to method of application »

JOB PURPOSE

• To support the implementation of quality and patient safety; enforce compliance with the hospital quality program across assigned departments, working together with the unit leadership and carrying out scheduled quality audits, guiding in corrective action formulation and implementation.
• To support the implementation of utilization management across assigned clinical departments in order to deliver cost effective patient care and address risk.
• To provide Physician liaison and clinical corporate client support, working closely with care managers.

RESPONSIBILITIES

Coordination of development/review of quality and patient safety policies, procedures and processes.

• Provide support/guidance in the review of relevant policies to conform to the quality and patient safety standards of the hospital
• Lead the development of Policies and procedures where required.
• Support assigned departments in process reengineering to optimize operational efficiency and patient care

 Integration of the hospital quality program into the departmental/unit agenda.

• Guide the interpretation and implementation of developed policies and procedures in the context of the quality and patient safety framework.
• Constantly involved in the training and communication of quality and patient safety issues and standards/best practice throughout the assigned areas.
• Review accreditation and regulatory agencies survey /internal quality audit findings and support the development and implementation of corrective/preventive action plans to address non-compliance.

Support the enforcement and monitoring of compliance with the hospital quality program in assigned areas.

• Directs and supports the collection, measurement and presentation of data required for monitoring and improving quality and patient safety.
• Leads the Hospital in conducting Root Cause Analysis (RCA) for sentinel and adverse events
• Identifies opportunities for continuous quality improvement and supports the implementation of CQI activities in assigned areas.
• Support departmental leaders in identification of relevant utilization management indicators
• Support the implementation of departmental utilization management priorities.
• Support departmental leaders in the collection and application of utilization management data in quality improvement activities.

Support assigned departments in optimal resource utilization management.

• Support departmental leaders in identification of relevant utilization management indicators
• Support the implementation of departmental utilization management priorities.
• Support departmental leaders in the collection and application of utilization management data in quality improvement activities.

Support the collection and aggregation of utilization management data in clinical departments.

• Create department and physician-based databases for identified utilization management indicators
• Liaise with relevant clinical departments to ensure timely and complete utilization management data collection.
• Identify and recommend requisite IT support in utilization management data collection, aggregation and analysis.
• Provide timely utilization management outcome reports to the clinical director and clinical departmental leaders to facilitate utilization improvement initiatives.
• Support assigned departments to optimize utilization Management data collection and application

Creation and management of clinical departmental Quality Variance Reports.

•  In liaison with the clinical department, support persons and departmental leaders, support the creation of wholesome QVRs that incorporate all quality indicators for the department.
• Train departmental leaders and staff in utilization management data collection.
•  Identify gaps and challenges in timely data collection within the clinical departments and escalate to the clinical director for action.
• Support the departments in timely updates of the QVRs as set in policy, month by month.
• Liaise with the hospital statistician to achieve the integration of data in departmental QVRs into an institutional QVR.
• Coordinate the clinical departments support persons under the guidance of the clinical director for clinical quality data validation.

Aggregation and analysis of clinical audit data

• Aggregate data from clinical departmental audits for use by various stakeholders.
•  Analyze and organize clinical audit data to reflect trends and inform action planning.
•  Advice the clinical director on unfavorable trends in UM indicators for timely remedial action.

 Quality audit

• Continuously audit compliance with the hospital quality and safety program in assigned areas.
• Participate in scheduled periodic hospital-wide audit activities.

Physician Liaison

• Coordinate the closure of matters arising from physician feedback for improved physician satisfaction and participation
• Develop appropriate indicators and targets and regularly report performance.

Provide clinical support to corporate clients via care managers

• Liaise with care managers to address clinical complaints/challenges of corporate clients in a timely version.
•  Analyze clinical issues related to corporate clients and provide advice leading to the improvement of service contracts and risk management approaches

Other responsibilities

• Carry out any other lawful tasks as may be assigned by the Quality Director /COS from time to time.          

  Education Qualifications & Skills required

• Minimum Bachelors University degree in Nursing. A master’s degree is preferred.
• Must be registered with the Nursing Council
• Health Management background would be advantageous
• MS Office proficiency    
• Minimum of three years’ experience in direct and indirect clinical care activities in a healthcare institution.
• In-depth understanding of good clinical practice requirements.
• Have strong experience and knowledge of clinical monitoring functions with knowledge of clinical research. 
• Excellent problem-solving skills and the ability to manage multiple tasks.
• Excellent data analytical and presentation skills
• Good leadership/people skills.  
• Excellent communication, interpersonal and presentation skills
• Ability to work in multidisciplinary teams
• Ability to manage own workload and prioritize effectively.
• Effective time management and organizational skills