Develop and maintain data quality monitoring frameworks, including defining key data quality metrics and thresholds
Build and maintain quality dashboards and reports using programming languages (e.g., SQL, Python) and BI tools to provide near real-time study insights
Ensure compliance with ICH-GCP, 21 CFR Part 11, HIPAA, and applicable FDA expectations for regulated SaMD trials
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Oversee the clinical data lifecycle for a portfolio of studies: ensuring timelines and data integrity are maintained.
Identify data-related risks and implement mitigation strategies, while driving process improvements and adopting emerging technologies as needed.
Develop and oversee the design of Case Report Forms (CRFs) and electronic data capture (EDC) systems to ensure accurate, complete, and protocol-compliant data collection.
Oura's mission is to empower every person to own their inner potential by providing insights on readiness, activity, and sleep quality through their Oura Ring and connected app. As a quickly growing company, they ensure that their team members have what they need to do their best work — both in and out of the office.
Lead end-to-end data management activities for clinical and/or consumer health studies.
Ensure compliance with CDISC standards (SDTM) and regulatory requirements.
Collaborate with cross-functional global teams (UK stakeholders, biostatistics, clinical, programming).
ClinChoice is a full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific and their employees are the most valuable company asset.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Accurately enter clinical trial data into Electronic Data Capture (EDC) systems.
Perform validation and quality checks to ensure data completeness and accuracy.
Work collaboratively with clinical research coordinators and site staff to resolve discrepancies.
UniTriTeam provides operational, administrative, and technology support to clinical research sites. They advance medicine and make a real impact in healthcare.
Independently oversees all aspects of study site management to ensure patient safety is protected.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.
Precision Medicine Group is expanding its capabilities across Latin America. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.