Clinical Data Science Associate

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September 24

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RQM+

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Healthcare Insurance • Biotechnology • Artificial Intelligence

RQM+ is a global MedTech service provider that accelerates compliance and market success for medical device and in vitro diagnostics (IVD) companies. Offering comprehensive services throughout the product lifecycle, RQM+ specializes in regulatory and quality consulting, lab services, clinical trials, and reimbursement strategies. With a team of seasoned consultants, many of whom are former FDA and EU regulators, the company provides unmatched expertise in handling complex regulatory environments. Jordi Labs, a subsidiary, enhances the service offering with advanced materials science and chemical characterization capabilities. RQM+ utilizes innovative platforms like Fern. ai to streamline regulatory documentation and expedite market entry for life-saving medical technologies.

501 - 1000 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

📋 Description

• 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 and assist in reconciliation specification development. • 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 and SOPs; ensure studies are ‘audit-ready’. • Perform periodic TMF reviews related to Data Management documents to identify gaps or outdated files and update TMF accordingly. • Support coding of events/histories/medications using MedDRA and WHO DD licenses. • Support data entry needs and development of project-specific procedures as required. • Support user access review to ensure appropriate EDC access and assist the Clinical Data Manager with database locking. • Responsible for data archival at the end of the trial in support of the Project Management team.

🎯 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. • Proficiencies in planning and organization.

🏖️ Benefits

• Industry leading compensation package • Deeply engrained focus on work life balance • Ongoing learning and development (company invests heavily in professional development) • Rewarding place to work; membership in the RQM+ family • Remote work (United States - Remote)