The Clinical Data Science Associate role at RQM+ is designed to provide essential support in the setup, execution, and closeout of clinical trials, ensuring data integrity and compliance within the Trial Master File (TMF). This role aims to accelerate innovation to patient impact by supporting the Clinical Data Science Lead and broader Data Operations teams in managing clinical trial data.
Requirements
- Competency in MS Products such as Word, Excel and Powerpoint
- Strong technical skills and computer literacy
- Preferable 1-2 years of experience in Clinical Data Management
- Assist the Clinical Data Science Lead with setup activities including eCRF development, edit check specification review, and DMP/eCCG documentation preparation
- Participate in User Acceptance Testing (UAT) of the Electronic Data Capture (EDC) system by executing test scripts, tracking results, and ensuring issues are entered into the UAT issues logs
- Perform ongoing review of Data Management listings to identify missing, inconsistent, or out-of-range data
- Support review of reconciliation listings (e.g., central labs) to ensure accuracy and completeness of cross-system data
Responsibilities
- Perform system validation
- Monitor clinical trial data through listings reviews and external data reconciliations
- Ensure documentation compliance within the Trial Master File (TMF)
- Assist the Clinical Data Science Lead with setup activities including eCRF development, edit check specification review, and DMP/eCCG documentation preparation
- Participate in User Acceptance Testing (UAT) of the Electronic Data Capture (EDC) system by executing test scripts, tracking results, and ensuring issues are entered into the UAT issues logs
- Responsible for query generation/resolution for data operations throughout the study conduct phase
- Perform ongoing review of Data Management listings to identify missing, inconsistent, or out-of-range data
Other
- Bachelor’s Degree or Master’s Degree in Science, Biomedical Engineering, Life Sciences, or related field.
- Strong interpersonal and communication skills, with ability to effectively collaborate across disciplines and with external partners.
- This position is well-suited for individuals looking to gain deep experience in clinical data science within a fast-paced, cross-functional environment.
- Strong interpersonal communication skills.
- Proficiencies in planning and organization.
