Clinical Data Science Associate

RQM+

95d

About The Position

The Clinical Data Science Associate provides essential support in the setup, execution, and closeout of clinical trials by assisting the Clinical Data Science Lead / Manager and broader Data Operations teams. This role is responsible for performing system validation, monitoring clinical trial data through listings reviews and external data reconciliations, and ensuring documentation compliance within the Trial Master File (TMF).

Requirements

• 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.
• Preferable 1-2 years of experience in Clinical Data Management.
• Competency in MS Products such as Word, Excel and Powerpoint.
• Strong technical skills and computer literacy.
• Strong interpersonal communication skills.
• Proficiencies in planning and organization.

Responsibilities

• 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.
• Ensure completeness and timely filing of startup documentation in the Trial Master File (TMF).
• 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; escalate issues to the Clinical Data Science Lead as appropriate.
• Support review of reconciliation listings (e.g., central labs) to ensure accuracy and completeness of cross-system data.
• Generate and distribute regular status reports and help track query aging and resolution rates.
• Maintain agendas and meeting minutes for internal and external meetings involving data operations.
• Track document completion timelines to ensure adherence to study milestones and TMF readiness.
• File and QC study documentation in the Trial Master File (TMF), ensuring compliance with ICH-GCP, SOPs and ensuring that studies are considered ‘audit-ready’ at all times.
• Perform periodic TMF reviews related to Data Management documents to identify gaps or outdated files and work with Data Operations teams in making sure that the TMF is up to date for Data Operations.
• Supports coding of events/histories/medications using MedDRA and WHO DD licenses.
• Support data entry needs if required within a study.
• Support in the development of any related project specific procedures.
• Supports the user access review to ensure that access is restricted to users in need of EDC access.
• Supports the Clinical Data Manager (CDM) with the locking of the database.
• Responsible for the delivery of the archival of the data at the end of the trial in support of the Project Management team.

Benefits

• Industry leading compensation package
• Focus on work life balance
• Ongoing learning and development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees