- Insmed Incorporated (San Diego, CA)
- …guidelines and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software ... strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving timely and high-quality ... management deliverables supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops,...(DMP), case report forms (CRFs), edit check specifications, and data validation rules. + Manage database design,… more
- Insmed Incorporated (NJ)
- …guidelines and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance ... will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- BioAgilytix (San Diego, CA)
- …and execute validation and sample analysis plansReview and evaluate PK/TK data and ISR results to identify trends and outliersPlan and execute cross-site ... you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableCTT member:Participate and represent BiostatisticsReview and ... The Senior Manager , Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of… more
- Stanford Health Care (Palo Alto, CA)
- …ICD coding structures, and billing forms (UB, 1500). + Experience with coding, clinical validation , and medical necessity for inpatient stays. + Knowledge of ... States of America) **This is a Stanford Health Care job.** **A Brief Overview** Clinical Government Audit Analyst and Appeal Specialist II plays a critical role in… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …guidelines, coding requirements, and regulatory changes + Participate in clinical validation denials review and value measurement/financial sustainability ... as liaison between CDI, coding, providers, and other teams to facilitate accurate clinical documentation + Assists CDI manager with ongoing quality assurance… more
- BeOne Medicines (Emeryville, CA)
- …and understanding of clinical database design / study build / data validation and system interoperability + Competence with project management skills ... Senior Manager , CDM Systems Administrator is responsible for leading...+ Manage user, site and subject administration support to clinical applications utilized by Clinical Data… more
- BeOne Medicines (Emeryville, CA)
- …work of staff in support of clinical trials, ad-hoc analysis requests, data validation , etc. in accordance with all relevant statistical regulatory guidance ... **Position Summary:** **The Senior Manager , Statistical Programming is responsible for the organization of a statistical programming group that supports multiple… more
- BioAgilytix (Durham, NC)
- …is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including ... best suited for someone with deep expertise in method development, GxP-compliant validation , and both targeted and untargeted analysis using chromatography and mass… more
- Alameda Health System (Oakland, CA)
- …Imaging Education, Quality & Informatics Administrator leads accreditation cycles, manages clinical competency validation across all imaging modalities, oversees ... and performance reports to track metrics across regulatory, operational, and clinical domains. Use descriptive statistics and data visualization tools… more
- Stanford Health Care (Palo Alto, CA)
- …the technical direction of the Medical Director, the Testing Lab Operations Manager is responsible for the administrative and technical management of Technical ... to supervisors and support personnel as appropriate. The Testing Lab Operations Manager will be responsible for managing supervisors as well as directly supervising… more
- Stony Brook University (Stony Brook, NY)
- …+ Ensure data accuracy, integrity, and security across systems through validation protocols, monitoring, and reporting. + Partner with IT and campus stakeholders ... to translate business needs into system functionality, implement enhancements, maintain data integrity, and resolve technical issues. The role requires strong… more
- Bristol Myers Squibb (Indianapolis, IN)
- …at the RayzeBio manufacturing site in Indianapolis. The Scientist I - Method Validation will report directly to the Manager of Analytical Development at ... of data . + Prepare analytical test methods and method validation , verification, and transfer protocols and reports in accordance with applicable guidelines… more
- Terumo Neuro (Aliso Viejo, CA)
- **12521BR** **Title:** Sr. Manager , Clinical Data Management **Job Description:** The Senior Manager , CDM oversees clinical data management ... with development, validation , execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission. 6. Able to work… more
- University of Utah (Salt Lake City, UT)
- Details **Open Date** 10/03/2025 **Requisition Number** PRN43249B **Job Title** Clinical Data Manager I **Working Title** Clinical Data Manager I ... University of Utah seeks a motivated, self-starting, and detail-oriented Clinical Data Manager I to...not limited to the following: + Test and review data validation checks + Issue and resolve… more
- Bristol Myers Squibb (Madison, NJ)
- …clinical trials from study start to database lock. **Position Summary** The Senior Manager , Clinical Data Management is a leadership role considered ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** Clinical Data Management key focus is to ensure data… more
- CVS Health (Chicago, IL)
- …for 100+ million customers. The A&BC organization is looking to grow its Product team supporting Clinical Data Science & AI. Join us as we embark on an exciting ... This role requires a strong understanding of product management, clinical data , data science, and...+ Liaise with clinicians to get an understanding of clinical best practices, requirements, and validation of… more
- The Cigna Group (Bloomfield, CT)
- …mandated by regulatory needs. This position leads a team inclusive and not limited to a Clinical Data Governance Lead and a Clinical Data Steward. ... manner. As dQM depends on timely, standardized, and complete clinical data , this role is essential to...Data Quality Liaison** + Coordinate with analytics and validation teams to share discrepancies with providers (eg, missing… more
- Mount Sinai Health System (New York, NY)
- …initiatives + Serving as a clinical liaison to the quality and clinical data analytics team **Principal Duties and Responsibilities** **General** + Manage ... **Job Description** The Clinical Program Manager for Geriatrics and...quality committees and report outcomes to leadership. + Coordinate clinical data activities among clinical … more
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