- 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)
- …and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) ... periodic reviews, and audit trail reviews.What You'll Do: 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
- Merck & Co. (Rahway, NJ)
- …Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… 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
- Christus Health (Woodworth, LA)
- …of the patient's clinical status and care. Review final DRG and compare with clinical data gathered to ensure the DRG assigned is appropriated and that all ... accurate data required by CMS. Facilitates concurrent modifications to clinical documentation to insure commensurate reimbursement of clinical severity and… more
- University Health (Pleasanton, TX)
- …or computer science is preferred Three (3) years' related work experience in clinical data analysis is preferred. Project management experience with medical ... chart review and clinical data abstraction within an integrated health...an integrated health system is highly desirable. Experience in data scrubbing, data normalization, and validation… more
- BeOne Medicines (San Mateo, 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
- Luke Staffing (Agana Heights, GU)
- **INDEPENDENT LICENSED SOCIAL WORKER CASE MANAGER ** **SITE OF SERVICE:** . US Naval Hospital, Guam . Full Time **POSITION QUALIFICATION/REQUIREMENTS:** . ... last (3) three years as a Social Work Case Manager working in an out/inpatient setting. . **Licensure:** Current,...active, and unrestricted license to practice as a Licensed Clinical Social Worker in any one of the 50… more
- SOFIE (Totowa, NJ)
- …NJ Department | Radiopharmaceutical Contract Manufacturing Reports To | Production Manager , Radiopharmaceutical Contract Manufacturing Shift | TBD Compensation | TBD ... Essential Duties and Responsibilities Operate, maintain, and report process data from automated and semi-automated radiopharmaceutical manufacturing equipment. Prepare… more
- Parexel (Oklahoma City, OK)
- …the case processing cycle + Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs) + Provide ... timeframes. Perform medical assessment of safety alerts obtained from data mining activities + Perform signal validation ...attention to detail + An ability to assess the clinical relevance of medical data and to… more
- Terumo Medical Corporation (Elkton, MD)
- …products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part ... Operations. Additionally, the Senior Lab Technician is responsible for data review and trending, investigation support activities, test instrument calibrations… more
- Stony Brook University (Stony Brook, NY)
- …programs. Such work may consist of, but is not limited to: performing data entry; math or calculations; mail, supply, and inventory functions; keyboarding and other ... corrections for format, accuracy, and validity. + Assist in gathering or compiling data for reports, graphs, charts, tables, or other products. + Create graphs,… more
- Caris Life Sciences (Phoenix, AZ)
- …Proficiency Testing in a timely manner and submits results to Supervisors. + Conducts validation testing for new clinical assays. + Tracks, enters, and monitors ... correct the problems or im-mediately notify the general super-visor, technical supervisor, clinical consultant, manager or director. + Document all corrective… more
- GRAIL (Durham, NC)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to ... (CAPA) investigations, Nonconformance (NCR) reporting, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), and Quality… more
- J&J Family of Companies (Raritan, NJ)
- …**Job Description:** Johnson and Johnson is recruiting for an **Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager ** , located in ... closing compliance gaps related to audits and inspections. The Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager is responsible for… more
- Astellas Pharma (Westborough, MA)
- …Westborough, MA as products move through clinical trials and commercialization. The Validation Manager will be a leader and SME accountable for capital ... ** Validation Manager ** Do you want to...of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and… more
- UPMC (Pittsburgh, PA)
- …does allow flexibility on start and end times. Under the direction of the Senior. Manager , the Data Validation Coordinator monitors, validates, tracks and/or ... help move UPMC forward with MU (Meaningful Use/governmental) requirements.Scope of the Data Validation Coordinator: Manage the overall abstraction results and… 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
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