Research Data Manager (KEN SHE Study) at Kenya Medical Research - KEMRI

Study Description

The KEN SHE Study is a prospective, blinded randomized study that will test the efficacy of single-dose bivalent and nonavalent HPV vaccination as a catch-up strategy.

Position: Research Data Manager (1 Position) KMR6 Vacancy No. FN-02-05-2021) K MR6 Vacancy No. FN-10-03-2021

Reports to: Study Coordinator

Duration: 1 Year Renewable Contract as per KEMRI Scheme of Service. The first 3 months is a probation period

Duties and Responsibilities

• Overseeing daily data activities
• Oversee data clerks duties
• Conduct training of all data clerks and relevant staff on data specific items, study protocol, SOPs and documents, equipment use
• Creating and maintaining all study database
• Updating and overseeing databases updates
• Generating study summaries and reports as required
• Arranging screening, enrolment and follow up files for daily schedules
• Performing QA/QC of electronic and paper Case report forms (CRFs), clinical chart notes and name chart, ensures competency at all QC levels Printing CRFs and arranging them in study binders
• Faxing and refilling of CRFs as needed
• Communicates with CC on behalf of data in relation to QC, supplies, CRFs updates and changes in CRFs.
• Spearheads the randomization process and ensures the process is smooth
• Ensures Label printing and delivery to the clinic team
• Spear heads analysis and resolution of DFNet queries
• Organizes eligibility meetings, tracks the screen/enrollment participant status records and provides daily reports.
• Develops all data related SOPs
• Assist staff in data analysis e.g. abstract writing
• Ensures data printers and data fax machines are maintained and stored well.
• Maintain data supplies inventory
• Manage study data
• Tracking of all study documents, data and storage
• Ensures archival procedures of all study data, hard and soft is secured and stored well
• Ensures confidentiality and safe storage of all participant identifying materials like link logs are kept confidentially.
• Gives QA/QC monthly and weekly reports
• Provide weekly site data reports
• Ensure biometric data capture of all study participants- configuration and programming, registration and verification of participants.

Required Qualifications

• Bachelor’s Degree in Statistics/ Applied Statistics/Biostatistics/Computer science
• Conversant with statistical packages i.e. Stata, SPSS, R, SAS.
• Conversant with data management databases i.e. MS access, Excel SQL or Visual basics.
• Basic IT skills i.e. Software installations, printer installations and trouble shootings.
• Having experience with data fax transmission machine is an added advantage.

Experience

At least two (2) years Clinical research experience is an added advantage

Desirable Qualities

1. Leadership skills to promote creativity and innovation.
2. Excellent verbal and written skills, good organizational, interpersonal, and team skills.
3. Applicable knowledge working with other clinical databases e.g. SAS, etc.
4. Experience with working on Phase I- IV study trials within a clinical set up.
5. Organizational and time management skills.
6. Must have strong written and verbal communication skills, project management skills, computer skills, and database skills.
7. Ability to lead a team of workers