Clinical Data Science Associate

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don't make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

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).

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; elevate 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. Work with the Clinical Data Science Lead with the development of reconciliation specifications.
• 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.

Requirements

Behaviors

Supervisory Responsibilities

Work Environment / Physical Demands

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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