Job Description
Position: Data Manager, J/G KMR 6 (1 position)
Location: Kisumu/ Siaya
Duration: One (1) renewable
Reporting to: Principal Investigators
Job description
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
i. Support, in collaboration with the NIH data support team, the development of the clinical trial database specifications, eCRFs, user requirements, edit rules/checks, query logics and data validation rules within the DF Discover system
ii. Develop and maintain data management plans, standard operating procedures for conducting data management activities for the trial including backup systems for power and internet
iii. 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
iv. 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
v. Design and implement procedures for automation of data outputs and regular statistical reports and configure dashboards for data visualization and other products for information dissemination
vi. Provide training and mentoring to research staff and study teams on data management processes and mentor data clerks and interns
vii. 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
viii. Extract data and perform regular reviews to identify issues, generate queries, and track their resolution working with the program staff and supervisors for corrective
action/query resolution in a timely manner
ix. 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
x. Ensure good internet connectivity for data entry at the trial sites and troubleshoot as needed
xi. Work with the study team to ensure that data reporting needs are scheduled and addressed
xii. Manage and supervise the daily data collection at the field sites
xiii. Participate in planning meetings and scheduled conference calls with the study team and study partners
xiv. Perform additional duties as may be assigned by their supervisor
Qualifications:
1. BSc in Computer Science, Biostatistics, Applied Statistics, or any other related field. A
master’s degree will be an added advantage.
Skills & Abilities:
2. Excellent organizational skills, attention to detail and a focus on quality and innovation
3. Ability to prioritize work, exercise initiative and work with minimal direction
4. Ability to manage multiple studies of medium complexity or size concurrently
5. Adaptability to changes in work duties, responsibilities, and requirements
6. Excellent communication and problem-solving skills
7. Ability to work independently and collaboratively with colleagues, including research
scientists
Terms of Employment: One (1) year renewable contract as per 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 supplemental amounts.