Overview

Position Title: Study Manager

Report to: Associate Director-, Clinical Research

Location: Mbabane, Eswatini,

Overview

ICAP-Eswatini, in partnership with the Ministry of Health, and with funding from multiple sponsor agencies is conducting a number of research studies including clinical trials and implementation science studies to respond to pertinent research questions in the HIV and COVID-I9 response.
Overall job Function: Working with the Associate Director for Clinical Research, the Study Manager will be responsible for implementing, monitoring and supervising clinical trials and other research activities in the portfolio. S/he will have the main role of leading work-plan development and coordination of research implementation of the designated project/s; according to the specified timelines on a day-to-day basis.

Roles and Responsibilities:

• Develop implementation work-plans

• Recruit, train and supervise study staff

• Ensure seamless coordination between departments and activities e.g. clinical, pharmacy, laboratory, and logistics.

• Oversee implementation of QC/QA procedures, ensuring coordination between staff engaged in the process.

• Develop standard operating procedures, job aids, and other study tools

• Develop training materials, and conduct training

• Overall responsible for study documentation for the designated study; including IRE submission packages, regulatory files, staff files, training records, QC/QA records, and source documents.

• Identify and report adverse events, protocol non-adherence events and field incidents within designated timeframes, design and implement Corrective Actions/Preventive Actions (CAPA).

• Responsible for monitoring of key study metrics to ensure work-plan milestones are met e.g. in participant accrual, participant retention, and visit adherence.

• Compile and submit designated study reports, organize stakeholder meetings

• Carry out other duties and responsibilities as assigned.

Education:

• A degree in Nursing, Epidemiology, Public Health, Medicine or other health related field. Good clinical practice certificate.

Experience, skills, Minimum Qualifications:

• At least 3 years of experience in clinical research, surveillance, surveys or other health research.

• Experience in conducting facility-based clinical trials or studies related to infectious diseases.

• Experience in participating in research and data quality control and supervising study staff, team building and management.

• Experience ethical review processes

• Certification in Good Clinical Practice

• Detail oriented and highly organized, able to multi-task and manage short deadlines

• Willingness to spend substantial time at clinical site, and the field.

• Team oriented but also highly self-motivated

• Proficient in Microsoft Office Suite applications.

• Excellent interpersonal, organizational, verbal and written communication skills.

How to Apply Interested applicants should logon to https://icapacity.icap.columbia.edu and follow the instructions. Closing date for applications to be submitted: Friday, 16 October 2020 at 17:00pm.

Please do not attach any certificates when submitting on line. Only short listed applicants will be contacted with preference given to qualifying Swati nationals. Please consider your application unsuccessful if you don’t hear from us 3 weeks after the closing date