Clinical Trial Manager job at MRC Uganda | Apply Now

Trial Coordination Support.

• Coordinate with sponsors, CROs (Contract Research Organizations), and other stakeholders to ensure smooth execution of clinical trials;

• Provide support to PIs to ensure patient recruitment, enrolment, and follow-up processes; and,

• Monitor progress, resolve issues, and ensure data integrity and accuracy.

Clinical trial support.

• Support development of risk-based monitoring plan;

• Conduct pre study/site selection visits, site initiation visits including participating in the activation/green light process, interim visits and close-out visits;

• Provide on-site monitoring according to the clinical trial protocol, monitoring plan and Unit procedures;

• Review informed consent process and documentation at trial site;

• Review source data, Serious Adverse Events (SAE) and all trial related documentation for accuracy, contemporaneity and completeness;

• Positively and effectively communicate and discuss monitoring findings with investigator teams;

• Facilitate the development and implementation of corrective action plans;

• Prepare accurate and timely monitoring reports and follow-up letters;

• Follow-up issues and corrective actions consistently, effectively and timely;

• Proactively engage research teams to pre-emptively identify and address areas of concern;

• Deliver a range of remote monitoring activities, including review of trial data;

• Critically review monitoring reports for trials monitored by external parties, including acting as a point of contact for external monitors;

• Participate in internal and external audits/inspections;

• Participates in the maintenance of the Investigator Site File (ISF) and Trial Master File (TMF) where applicable;

• Check trial facilities are adequate, including storage areas (drugs, records), labs, spaces for treatment and informed consent storage and other areas;

• Confirm investigational products are handled, stored and used in line with the protocol, Investigational Product (IP) Manual and Unit Standard Operating Procedures (SOPs);

• Ensure samples and records are stored appropriately with adequate environment controls; and,

• Participate in reciprocal monitoring of studies conducted at the Unit and collaborating institutions.

Quality Assurance.

• Conduct regular audits and quality checks to ensure adherence to SOPs and regulatory requirements;

• Prepare sites for monitoring, audits, and inspections; and,

• Implement and assess corrective actions for any identified issues or non-compliance.

Regulatory Compliance.

• Ensure all clinical trials are conducted in compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) requirements, and other regulatory guidelines;

• Maintain up-to-date knowledge of relevant regulations and ensure the clinic’s practices adhere to them through training and other procedures;

• Guide PIs to prepare and submit necessary documentation for ethics and regulatory approvals; and,

• Guide PIs to maintain essential documents.

Communication and reporting.

• Maintain clear and effective communication with investigators and other key stakeholders; and,

• Prepare and present regular reports on trial progress, operational issues, and performance metrics.

Clinical trial support.

• Act as a focal point for communication with the trial team for Unit sponsored trials and contact site staff regularly;

• Register clinical trials on public databases and update entries, as required;

• Ensure that SAEs and other reportable events are well documented and appropriately reported and followed up;

• Review Data Safety Monitoring Board (DSMB) and Trial Steering Committee (TSC) charters for Unit Sponsored trials, as applicable;

• Oversee that Unit sponsored studies are well managed and delivered to expected timelines;

• Maintain appropriate Sponsor records for Unit sponsored trials;

• Ensure that trials are conducted in line with the principles of ICH Good Clinical Practice (GCP), regulatory requirements and ethical guidelines;

• Participate in ensuring compliance to GCLP and ISO 15189 including re-accreditation activities;

• Participates in preparing regular trial updates to oversee recruitment rate and compliance;

• Train staff on the ethical and regulatory requirements, GCP, HSP, study protocols, consenting procedures, study tools and SOPs among others in liaison with the training department whenever applicable;

• Participate in trainings conducted by the department;

• Pro-actively participate in guiding and supporting investigators in completing pre-trial activities required for Sponsor study-start approval; and,

• Support development and review of trial-specific risk assessments.

Others.

• Participate in the development and review of Department/Unit SOPs;

• Conduct monitoring of other studies conducted at the Unit;

• Participate in meetings;

• Maintain department databases, trackers and resources;

• Support department administration;

• Drive and advocate for good research practice at the Unit;

• Collaborate and work closely with the study teams;

• Willing to undertake local and international travels to undertake monitoring activities; and,

• Undertake any other duty assigned by their line manager within the broader remit of the post.

Line Management responsibilities.

• Supervises the clinical trial monitors and the clinical trial assistants.

LSHTM Integration.

• Participate positively and proactively in the process of integrating and harmonising procedures across all LSHTM sites; and,

• Participate in activities across the Unit in Uganda and Gambia, and the wider LSHTM.

Environment.

• Develop strategies to reduce adverse environmental impact of the Research Governance department;

• Participate in carbon emission reduction activities across the Unit and wider LSHTM; and,

• Act as an advocate for the responsible and efficient use of resources.