Reporting to the Data Manager and Laboratory Manager, the Senior Data Quality Officer will manage the implementation of research projects to ensure appropriate adherence to protocols, documentation, and data accuracy. In accordance with the Clinical Quality Management Plan (CQMP), the Senior Data Quality Officer will collaborate with a multidisciplinary team under the Global TB department to perform data management and quality assurance and control (QA/QC) mainly in the Laboratory. The Senior Data Quality Officer will ensure the biorepository samples tracker is backed up on the cloud, aligned, and integrated with RedCap. In order to follow up on data queries, address them, and create and implement solutions that support QA/QC of all study data, the Senior Data Officer will communicate with the relevant study teams (Laboratory and Clinical teams).
SPECIFIC DUTIES AND RESPONSIBILITIES
Duties include but are not limited to the following:
- Oversee Redcap data entry in the Lab, which includes assembling, retrieving, and filing binders.
- Assist with entering data into the appropriate Lab data platforms, ensure the biorepository and Redcap data are linked, and perform regular QC.
- Create and manage systems, such as Standard Operating Procedures (SOPs), trackers, and other documents, that enable accurate and timely data entry and corrections.
- Collaborate with the clinical team to guarantee prompt data entry into the appropriate data platforms and prompt query resolution.
- Create and carry out data queries and data cleaning as needed in compliance with the CQMP and study SOPs.
- Work with the clinical team and laboratory team to coordinate answering and fixing data queries and updating the database
- Carry out routine QA/QC tasks in compliance with the CQMP.
- Generate reports on quality control and internal data in order to direct and evaluate site operations.
- As appropriate, conduct refresher or training sessions on the study’s quality and data.
- Work along with the relevant study retention team to oversee the lab query resolution system is always current and completely working.
- Control access to the study information to guarantee participant anonymity and data security. Additionally, maintain mechanisms that make retrieving files and study documents simple.
- Conduct routine maintenance on research computers and electronic equipment, including password and encryption reviews.
- Carry out any additional tasks as assigned.
Minimum Qualifications and Experience
- A bachelor’s degree in computer science, information technology, or a similar field.
- Three to five years of relevant experience managing longitudinal data and maintaining databases in clinical research.
- Experience working with Lab data.
- Capacity to create trackers and laboratory data management SOPs.
- GCP, HSP, and HIPAA training.
- A minimum of three years experience in data analysis, data management, and report writing
- A minimum of two years experience in biostatistics or bioinformatics
- Ability to work with Database Systems such as Redcap, including adding and updating records and fields, changing the database layout, and creating customised reports.
- Ability to collaborate with other team members on tasks, such as the resolution of data queries.
Skills/Abilities/Aptitudes Requirements:
- Fluency in SiSwati and English
- Honesty and integrity
- Computer skills in Microsoft Office
- Ability to work as a highly cooperative member of a team.
- Ability to meet deadlines with flexibility to adapt to rapid program growth and a dynamic work environment.
- Ability to function with mature judgment, tact, and diplomacy, ensuring that protection of study participants and good clinical practice is adhered to at all times.
- Maintenance of strict confidentiality and professional etiquette to sensitive study participant information.
- Ability to work with minimum supervision and adhere to COE policies.
- Knowledge in R and other research data analysis software, including aptitude with Python, Jupyter notebooks, SQL, or other Application Programming Interface (API) software for integrating data across databases
- Flexibility to work on off working hours
Special Requirements
- Ability to pay attention to detail
- Maintain professionalism at work
- Ability to work with minimum supervision
- Must be a Team player
- Experience in working with multi-discipline and multi-cultural team.
Applications
Applications to be addressed to the Executive Director, Baylor College of Medicine Children’s Foundation- Eswatini, and sent ONLY by email to: citing the position applied for, your Name and Surname in the email subject.
All applications should be accompanied by a cover letter, curriculum vitae (CV) and certified copies of certificates. Faxed applications, posted or hand delivered applications will NOT be considered. No calls. Only short- listed candidates will be contacted.