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Clinical Trials Manager job at MRC/UVRI and LSHTM Uganda Research Unit | Apply Now

Are you looking for Medical jobs in Uganda 2024? If yes, then you might be interested in Clinical Trials Manager job at MRC/UVRI and LSHTM Uganda Research Unit

Kampala, Uganda

Full-time

Deadline: 

12 Jul 2024

About the Organisation

The MRC/UVRI & LSHTM Uganda Research Unit is an internationally recognized centre of excellence for research and training. The Unit was established in 1988 to improve the understanding and control of the HIV epidemic in Uganda and globally, following a request from the Uganda Government to the United Kingdom (UK) Government. After wide consultations, and in response to the changing public health landscape, Unit work has broadened beyond HIV to include other infections, neglected, endemic, emerging and re-emerging infections and non-communicable diseases (NCDs).

Job Title

Clinical Trials Manager job at MRC/UVRI and LSHTM Uganda Research Unit

Job Description

The unit is an internationally recognised centre of excellence with cominant research themes in the areas or HIV and emerging infections, vaccines and immunity, and chronic diseases and cancer. Through a multidisciplinary approach, intersecting basic science, epidemiological research, social-behavioural research and the conduct of new intervention evaluation studies, the Unit contributes knowledge on changi epidemics and diseases, the evaluation of innovative health care options, treatment and prevention and the development of health policy and practice in Africa and worldwide. Following the signing of strategic transfer agreements between the London School of Hygiene & Tropical Medicine (LSHTM) and the Medical Research Council (MRC UK), the Unit formally joined LSHTM on 1st February 2018. The exciting new partnership will boost research capacity into current and emerging health issues in Africa and throughout the world. The Unit is based at the UVRI Entebbe campus with established outposts in Kalungu, Masaka, Wakiso and Kampala Districts.
The Unit is now seeking enthusiastic and experienced individuals to fill the following positions:

Job Purpose;
The position holder will be involved in high-level coordination of the LSHTM Clinical Trials Network, shaping its direction and collaborating globally to promote best practices and optimize trial capacity. The candidate should have extensive experience in clinical trials, especially in resource-constrained settings, and strong health research management skills. The role offers an exciting opportunity for a dynamic individual to advance LSHTM's strategic priorities.

Duties and Responsibilities

Trial Planning and Design

  • Develop and implement trial protocols, study designs, and methodologies.

  • Coordinate with researchers, sponsors, and regulatory bodies to ensure trial objectives and compliance.

  • Create and manage timelines, budgets, and resources for clinical trials.


Regulatory Compliance

  • Ensure that trials comply with all relevant regulations, guidelines, and ethical standards (e.g., FDA, EMA, ICH-GCP).

  • Prepare and submit regulatory documents, including Investigational New Drug (IND) applications and Institutional Review Board (IRB) submissions.

  • Maintain up-to-date knowledge of regulatory changes and implement necessary adjustments to trial protocols.


Site Management and Monitoring

  • Select and manage trial sites, ensuring they have the necessary resources and capabilities.

  • Conduct site visits to monitor progress, adherence to protocols, and compliance with regulatory requirements.

  • Resolve any issues that arise at trial sites and provide support to site staff.


Data Management and Analysis

  • Oversee data collection, entry, and validation processes to ensure accuracy and completeness.

  • Coordinate with data management teams to develop and implement data management plans.

  • Analyze and interpret trial data, ensuring the integrity and validity of results.


Team Coordination and Leadership

  • Lead and manage cross-functional teams, including clinical research associates, data managers, and other support staff.

  • Provide training and support to team members to ensure adherence to protocols and best practices.

  • Foster a collaborative and productive work environment.


Participant Recruitment and Retention

  • Develop and implement strategies for participant recruitment and retention.

  • Monitor participant enrollment and retention rates, addressing any issues that arise.

  • Ensure informed consent is obtained and documented for all trial participants.


Reporting and Documentation

  • Prepare regular progress reports, safety reports, and final trial reports for sponsors, regulatory bodies, and other stakeholders.

  • Maintain comprehensive and accurate documentation of all trial activities and findings.

  • Present trial results at meetings, conferences, and in publications as required.


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Qualifications and Competencies

Educational Background

  • Bachelor’s degree in life sciences, healthcare, or a related field. Advanced degrees (e.g., Master's, PhD, MD) are often preferred.

  • Certification in clinical research (e.g., Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC)) is advantageous.


Experience

  • Several years of experience in clinical trial management, clinical research, or a related field.

  • Experience with various phases of clinical trials (Phase I-IV) and a thorough understanding of trial design and methodology.


Technical Skills

  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

  • Familiarity with statistical software and data analysis tools.

  • Strong understanding of regulatory requirements and guidelines (e.g., ICH-GCP, FDA, EMA).


Project Management Skills

  • Strong project management skills, including the ability to manage multiple trials simultaneously.

  • Experience in budgeting, resource allocation, and timeline management.

  • Ability to develop and implement project plans, monitor progress, and make adjustments as needed.


Analytical and Problem-Solving Skills

  • Excellent analytical skills to interpret trial data and identify trends and issues.

  • Strong problem-solving abilities to address challenges and ensure trial success.


Communication and Interpersonal Skills

  • Excellent written and verbal communication skills for preparing reports, protocols, and presentations.

  • Strong interpersonal skills to build relationships with trial sites, regulatory bodies, sponsors, and team members.

  • Ability to lead and motivate cross-functional teams.


Attention to Detail

  • Strong attention to detail to ensure accuracy in data collection, documentation, and reporting.

  • Commitment to maintaining high-quality standards throughout the trial process.

  • Career Path and Progression

  • Entry-Level Roles: Starting positions might include Clinical Research Coordinator, Clinical Research Associate, or Clinical Trial Assistant.

  • Mid-Level Roles: Progress to roles such as Senior Clinical Research Associate, Lead Clinical Data Manager, or Clinical Operations Manager.

  • Senior Roles: Advance to positions such as Clinical Trials Manager, Clinical Program Manager, or Director of Clinical Operations.

  • Executive Roles: Potential to move into executive positions such as Vice President of Clinical Development or Chief Medical Officer (CMO).

How to Apply

For detailed job descriptions and procedure for application, please follow the application link per position.
For future employment opportunities, please visit http://www.mrcuganda.org/jobs
The applications should be addressed to:
The Head of Human Resources,
MRC/UVRI and LSHTM Uganda Research Unit,
P.O. Box, 49, Entebbe, Uganda.
Only online applications through the link provided will be accepted. You will receive a notification in your email if your application has been successfully received. In the event you are selected as the best candidate for the job, it will be a requirement to present certified copies of academic documents prior to contracting.

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