Job Summary

Position: Data Officer – Clinical Trials Research (1 post)
Reports to: Project Principal Investigator
Work station: Bagamoyo

Institute Overview

Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute’s work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research and policy translation.

Position Summary

IHI is looking for a Data Manager to oversee and manage clinical trial data from design through to final delivery of clinical datasets to the sponsor. The manager will provide technical expertise in the management and processing of clinical data, within the trial to ensure that they are executed in an efficient, accurate and timely manner to the sponsor’s satisfaction.

Duties and Responsibilities

• Develop data management plan (DMP) to define the data collection and processing workflow and overseeing its
• Oversee and mentor data clerks’ and data officer’s duties
• Train all data clerks and other study staff on data specific items, study protocol, SOPs and documents, equipment use.
• Develop source document and case report forms (CRFs) for the
• Review CRF and specify checks and perform
• Develop and maintain study Electronic Data Capture (EDC) system and the
• Generate study summaries and reports as
• Arrange screening, enrolment and follow up files for daily
• Perform QA/QC of Case report forms (CRFs) and, ensures competency at all QC
• Print CRFs and arranging them in study binders as
• Communicate with the Project Manager about data in relation to QC, supplies, CRFs updates and changes in CRFs.
• Ensure label printing and delivery to the clinic
• Spearhead analysis and resolution of data
• Track the screening/enrollment of participant, record their statuses and provide daily reports in liaison with the study
• Develop all data related SOPs and
• Maintain data supplies
• Track all study documents, data and
• Ensure archival procedures of all study data, both hard and soft, are followed and data are secured and stored
• Ensure confidentiality and safe storage of all participant identifying materials, such as link logs, are kept
• Gives QA/QC monthly and weekly reports.

Qualification and Experience

• Minimum of an undergraduate degree in Statistics, Applied Statistics, Biostatistics, or Computer Science.
• At least two (2) years of experience in data management and/or related work experience in a clinical research
• Familiar with statistical packages i.e. Stata, SPSS, R,
• Knowledge of Data Management full
• Basic IT skills i.e. software installations, printer installations and trouble
• Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Working knowledge of Clinical database applications such as EDC and CTMS and data management databases such as MS access, Excel SQL or Visual

Skills and Competencies

• Problem-solving / trouble-shooting
• Excellent written, verbal and organization
• Must be detail-orientated, and a self-motivator.
• Must be willing to take on additional projects and work overtime when necessary

Remuneration

An attractive and competitive remuneration package will be offered to successful candidates as per IHI salary scales.

Equal Opportunity

IHI is an equal opportunity employer. We prohibit intentional biases or discrimination and harassment of any kind at the work place and during recruitment. All employment decisions are based solely on job requirements and individual qualifications, and our recruitment process is governed by the labour laws of Tanzania.