Job Description
Project description
Kenya Medical Research Institute (KEMRI) Centre for Respiratory Diseases
Research would like to fill the following vacancy in the Clinical Trials Studies to
be conducted at the KEMRI-Mtwapa Clinical Research Site in Kilifi County.
Vacancy No. CRDR/07/09/23
JOB GRADE: KMR 6
REPORTING TO: Study Coordinator
Person specification:
• Be a holder of a bachelor degree in Statistics, Biostatistics, Mathematics,
Computer Science, or any related field from a recognized university.
• Have at least three (3) year experience in data processing, management,
and analysis in a health/medical research setting.
• Have excellent working knowledge and experience with at least one
statistical package for data manipulation and analysis (STATA, SPSS, SAS,
R) and one database management software (SQL Server, MS Access).
• Familiarity with modern database systems and information technologies
including cloud server management.
• Familiarity with EDCs such as REDCap, and ODK-based platforms such
as ODK Survey, CommCare, SurvetCTO, etc
• Be proficient in statistical and data management procedures, including
data cleaning, manipulation, summaries, tables, listings, graphics, and
inferential statistical output, as well as report generation.
Skills and Abilities:
• Strong analytical ability, planning, and organizational skills.
• Attention to detail
• Ability to work with minimal supervision and within stipulated deadlines
and schedules.
• Excellent interpersonal and communication skills.
• Be a team player and able to work in a multi-cultural environment.
Duties and Responsibilities:
• Develop and maintain throughout life cycle of study projects, the
Standard Operating Procedures (SOP), Data Management Plans (DMP),
Data Quality Plans, and other plans as delegated/required, and ensure
that these are followed according to study design/protocol and
requirements.
• Participate in study setup initiation, implementation, closure, and
archiving procedures: i.e., CRF design, database design, database edit
check’s, design/review, Data Management Plan review/approval and
annotated CRF design.
• Ensure Clinical database, external data files and analysis datasets are
designed in a standard, accurate, complete, and consistent format
conducive to analysis and possible regulatory submission.
• Develop, review, and approve all SOPs, and job aids related to Data
Management in collaboration with Quality Assurance and other
departments as applicable.
• Coordination of all data collection, cleaning and validation including,
working with the trial monitors (where applicable) and resolving any data
queries.
• Maintain and update study laptops/tablets and other equipment used for
data collection, ensuring data is downloaded daily/promptly and that
forms are updated as needed.
• Draft interim reports to the Principal Investigators, Sponsor, regulatory
authorities, and oversight committees as requested by the Site Trial
Manager.
• Training users to use electronic data capture (EDC) systems. This includes
creation of training documentation and running training sessions for end
users.
• Participate in planning meetings and scheduled conference calls with the
study team and study partners/collaborators.
• Ensure the conduct of the study is following the currently approved
protocol/amendment(s), with current GCP guidelines and with applicable
regulatory requirements.
Terms of Employment
One (1) year renewable contract as per KEMRI scheme of service with a probation
period for the first 3 months. Salary is as per the stated KEMRI scale.