The clinical trials manager will be responsible for reviewing and monitoring the implementation of systems and procedures for managing research study and as well provide technical support in line with the study protocol and GCP guidelines.

Overall Responsibilities
• Prepare and monitor the implementation of periodic study plan & budget then submit frequent/precise updates and monthly reports to the day to day supervisor, CRS & CTU coordinators as per the plan in line with study protocol and Baylor financial guidelines.
• 2. Develop, revise and monitor the implementation of study and site specific standard operating procedures (SOPs) to foster compliance to the study protocol in line with Research departmental mission.
• Periodically conduct internal research monitoring and auditing to enhance understanding and compliance of the research team members to the required research protocols/study source documents and make appropriate recommendations to the key stakeholders as per the status of research compliance in line with internationally acceptable research standards.
• Monitor implementation of guidelines for the appropriate documentation in terms of study documents & CRFs & as well as identification, management and timely reporting of all serious adverse events (SAE) and expedited adverse events (EAE) immediately to the site PI, study sponsors, local monitoring bodies and IRBs bodies on quarterly basis or as stipulated by the study protocol.
• Develop and maintain a competent & motivated “study team” through implementing HR support activities in line with the Human resources manual and Baylor Uganda research policy.
• Prepare protocols, investigator brochures and CRFs which include keeping track and monitoring re-ordering supplies for the research study and avail tracking and Investigator tools to the relevant stakeholders in line with Baylor-Uganda research policies
• Develop and monitor the implementation of periodic performance targets for study at team and individual level, and give performance based feedback to team and other key stakeholders in line with study protocol.
• Prepare all the necessary documents for protocol submission to relevant institutional research board (IRB) & other regulatory bodies and follow up all IRB approvals and amendments in line with Baylor-Uganda research policies.
• Develop and maintain collaborations and networks with investigators, ancillary institutions, research team, research participants, sponsoring organizations, and relevant regulatory bodies so as to have harmonized study related interventions in line with the Baylor Research policy and various study objectives.
• Monitor the Screening, enrolling and provision of clinical assessment and evaluation of health or illnesses of study participants as well as provision of individualized care and treatment in line with Study objectives.
Required Qualification, Experience and Competencies:
• A Masters degree in Public Health/Health Services Research/Management Studies or equivalent.
A Bachelor’s Degree in Nursing with Knowledge/ training in quantitative and qualitative research and must be registered with the Uganda Nurses and Midwives Council.
• 5 Years Relevant Experience

NOTE:
Applications should include a cover letter, CV, daytime telephone contact, three traceable professional references and certified UNEB certificates as well as certified University Transcripts
You must have at least a credit 6 in MATHEMATICS and ENGLISH at Ordinary Level (UCE). Only shortlisted candidates will be contacted for interview. Please note only shortlisted candidates will be contacted.
In case you have any further questions about the role, contact us on [email protected]