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Duration: One (1) renewable
Reporting to: Principal Investigators
The successful candidate will be responsible for the overall data management procedures for the clinical trial including data capture, monitoring the quality and integrity of data and preparing summary reports.
He/she will work with the Trial Coordinator, the Principal Investigators, and the data management team at NIH to design and implement a robust data management system and ensure data management is performed in accordance with the trial protocol, procedures, guidelines and professional standards of practice. S/He will ensure that all data is complete, accurate and timely and must be in compliance with the applicable guidelines and regulations. The holder of this position shall be expected to operate from
the KEMRI–CGHR field station in Kisian and the KEMRI–CGHR Clinical Research Centre in Siaya.
Duties and Responsibilities
- Support, in collaboration with the NIH data support team, the development of the clinical trial database specifications, eCRFs, user requirements, edit rules/checks, query logic and data validation rules within the DF Discover system
- Develop and maintain data management plans, and standard operating procedures for conducting data management activities for the trial including backup systems for power and internet
- Ensure quality and accuracy of data submitted from the study sites and assure timely entry and review of the database, query resolution and appropriate reporting and follow–up for all safety events by site personnel
- Create and maintain data management files, data dictionaries, and other required documentation in compliance with the national and international standards, regulations, and guidelines on data protection, governance, and sharing
- Design and implement procedures for automation of data outputs and regular statistical reports and configure dashboards for data visualization and other products for the information dissemination
- Provide training and mentoring to research staff and study teams on data management processes and mentor data clerks and interns
- Maintain study electronic devices such as laptops, tablets and other equipment used for data collection, ensuring data is secure and forms are updated as needed
- Extract data and perform regular reviews to identify issues, generate queries, communicate and track their resolution working with the program staff and supervisors for corrective action/query resolution in a timely manner
- Work with the Trial data management support team to ensure the EDC system can lock/unlock and freeze/unfreeze for statistical review, interim review and/or final database checks
- Ensure good internet connectivity for data entry at the trial sites and troubleshoot as needed
- Work with the study team to ensure that data reporting needs are scheduled and addressed
- Manage and supervise the daily data collection at the field sites
- Participate in planning meetings and scheduled conference calls with the study team and study partners
- Perform additional duties as may be assigned by their supervisor
- BSc in Computer Science, Biostatistics, Applied Statistics, or any other related field.
- A master’s degree will be an added advantage.
Skills & Abilities:
- Excellent organizational skills, attention to detail and a focus on quality and innovation
- Ability to prioritize work, exercise initiative and work with minimal direction
- Ability to manage multiple studies of medium complexity or size concurrently
- Adaptability to changes in work duties, responsibilities, and requirements
- Excellent communication and problem–solving skills
- Ability to work independently and collaboratively with colleagues, including research scientists
Terms of Employment:
One (1) year renewable contract as per the KEMRI scheme of service and a probation period for the first 3 months.
Remuneration: Compensation is negotiable within a relevant grade, based on education levels, relevant experience, and demonstrated competency. The salary scheme is based on the KEMRI scales plus
How To Apply
All the applications are to be done through KEMRI Website http://www.kemri.go.ke/e–recruitment – E-Recruitment Portal on or before 19th May 2022 latest 5.00 p.m.
Please visit the KEMRI website http://www.kemri.go.ke for more details on the advertisement.