Perform EDC validation UAT, data listings review, data issues tracking and query management, external data reconciliation, data listings review coordination.
Accountable for on-time and comprehensive review of clinical study data listings
Manages the effective communication of data issues and discrepancies to study sites via the query management process.
ClinChoice is a global 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.
Provide statistical leadership for clinical and/or consumer health studies
Develop and review Statistical Analysis Plans (SAPs)
Contribute to study design, including sample size calculation and protocol development
ClinChoice specializes 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 and aim to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Maintains responsibility of assigned projects and ensures on-time delivery.
Provides input and guidance to the design of clinical databases.
Develops, tests, and validates programs and clinical databases.
Precision Medicine Group is committed to improving the efficiency of medical treatments. They focus on applying precision medicine, supported by data, to enhance research and development in the healthcare sector and is an equal opportunity employer.
Responsible for the strategic oversight, operational management, and continuous improvement of the Trial Master File (TMF).
Lead TMF quality review activities, including ongoing completeness checks ensuring that all required documents are accurately filed.
Identify eTMF trends and commonly misfiled documents, and lead efforts to identify, communicate, and resolve document inconsistencies.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
Lead programming activities for oncology clinical trials across multiple studies.
Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
ClinChoice is a global 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 and consider their employees their most valuable asset.
Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.