RQM+ is the largest global MedTech CRO, offering consulting, clinical trial, lab and reimbursement services across the entire product lifecycle. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.

Clinical Data Science Lead

The Clinical Data Science Lead is responsible for leading the day-to-day execution of clinical data management activities at a project level. This role ensures high-quality, inspection-ready data through proactive planning, hands-on execution, and collaborative engagement across cross-functional teams and external vendors. The Clinical Data Science Lead plays a critical role in the successful delivery of clinical trials by owning the database lifecycle from design through final database lock.

Key Responsibilities

• Provide day-to-day operational support for clinical data operations activities across all studies assigned.
• Lead the design of the Case Report Form (CRF) in both paper and electronic formats, ensuring alignment with protocol requirements as well as sponsor/RQM+ standards.
• Oversee development of eCRF modules (e.g., randomization, adjudication, ePRO, eConsent and inventory/trial supply) and system edit checks within selected EDC platforms.
• Draft and finalize the Data Management Plan (DMP) and eCRF Completion Guidelines (eCCG), collaborating with RQM+ functional/sponsor leads.
• Create and execute User Acceptance Testing (UAT) scripts; coordinate UAT activities to ensure system readiness for Go Live.
• Ensure that the database is stable and ready to ‘go live’ ahead of First Patient In (FPI).
• Maintain and track deviations from the DMP through comprehensive documentation in the Data Management Report (DMR).
• Create, validate, and maintain Data Management Listings for ongoing review and cleaning of clinical trial data.
• Generate and deliver routine status reports and data summaries to study teams and management.
• Monitor data trends and site performance using oversight listings; performing targeted reviews to identify and address data quality issues.
• Review and manage EDC user roles and access throughout the study, coordinating with clinical operations to maintain compliance and access control.
• Support query resolution activities and ensure timely cleaning of clinical data.
• Provide independent support to other projects enabling a quality review audit of data by examining closed queries/sample number of subjects/listings to ensure that data is being validated accurately throughout the course of the study.
• Support the development/deployment of the clean patient tracker and use in the context of batch cleaning as a proactive means of cleaning data ahead of major deliveries such as interim analyses/database lock.
• Ensure all data entry, cleaning, documentation, coding, reconciliation, and issue resolution are complete before database lock.
• Archive and transfer study data in accordance with RQM+/Sponsor SOPs.

Key Requirements

• Bachelor’s Degree or Master’s Degree in Science, Biomedical Engineering, Life Sciences, or related field.
• Minimum of 5 years of relevant experience in clinical data management or data operations within the pharmaceutical, medical device and/or CRO industry.
• In-depth knowledge of ICH-GCP, FDA/EMA data regulations, as well as data privacy regulations (GDPR, HIPAA).
• Strong interpersonal and communication skills, with ability to effectively collaborate across disciplines and with external partners.
• Proficiency with multiple EDC systems including (but not limited to): Mednet Solutions, Medrio, Zelta, ClinInfo, and SecuTrial.
• Familiarity with SAS for data review is a bonus.
• Working knowledge in setting up databases in EDC platforms that may use modules outside of EDC such as Randomization, Adjudications, ePRO, eConsent, as well as Inventory/Trial Supply.
• Working knowledge of SAS and/or SQL programming.
• Experience working in set up, maintenance and locks for multiple projects in parallel.
• Working knowledge of MedDRA and WHO DD Coding.
• Excellent levels of communication and organizational skills including the use of MS Project for the creation and maintenance of timelines.
• Proficiency in working independently and performing effective oversight of DM operations, supporting and training the team as needed.