- Tris Pharma (Monmouth Junction, NJ)
- …PK/PD data from Phase 1-4 studies to support dose rationale and clinical development strategy.Author and review clinical pharmacology sections of ... (QSP) and mechanistic modeling where appropriate to integrate translational and clinical data .Partner with clinical scientists, biostatisticians, and… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …medical oversight during clinical trials to ensure participant safety and data integrity. Review and interpret safety signals, adverse events, and efficacy ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the ...data in collaboration with pharmacovigilance teams. Target Product Profile… more
- Eisai, Inc (Nutley, NJ)
- …routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study...discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related… more
- Insmed Incorporated (San Diego, CA)
- …for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency throughout the study ... standards and efficient processes in the implementation and integration of patient data systems . The candidate will collaborate closely with the Biometrics… more
- Eisai, Inc (Woodcliff Lake, NJ)
- …knowledge and participate in scientific exchanges and interactions with identified KOLs.Present clinical , scientific and economic data on Eisai's products and ... and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data .Demonstrate full knowledge of and… more
- Insmed Incorporated (NJ)
- …(CSV) and lifecycle management in clinical and/or laboratory environments.Knowledge of clinical systems (eg, EDC, IRT, eTMF, CTMS) and/or QC laboratory ... requirements. This role will support implementation and ongoing management of digital systems used in clinical trial operations, quality control laboratories and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and in ... across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and… more
- Merck & Co. (Rahway, NJ)
- …and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal ... strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s)… more
- Genmab (NJ)
- …high-quality clinical trial conduct and relationship quality through ongoing review , identification and resolution of issues and risks in partnership with ... within Genmab, the Site Engagement Manager role will bring a high-touch and clinical trial 'face' with our sites.Additionally, the Manager may also support on-site… more
- Carondelet St. Marys Hospital (Tucson, AZ)
- …protocols of the healthcare organization. Includes taking patient load and covering Clinical Lead position as needed. Provide financial review of administrative ... and staff development in collaboration with Network education including Information Systems courses, web based training, Team Building, Clinical Coach… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in-process, or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data .Utilize electronic systems (LIMS) for ... related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP...in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team setting… more
- Insmed Incorporated (NJ)
- …and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.Oversee ... QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and… more
- NORC (Washington, DC)
- …prescribing practice requirements, and interpretations of comparative effectiveness of outcomes based on clinical trial data + Utilize data and literature to ... to pharmaceutical drug prescribing practices + Develop protocols for and conduct clinical trial literature reviews and data extraction. + Conduct systematic… more
- Stanford Health Care (Palo Alto, CA)
- …of America) **This is a Stanford Health Care job.** **A Brief Overview** The Clinical Principal Systems Analyst I supports core functions of the health system's ... and safe patient care. This position will implement, administer, and support assigned systems under the minimal guidance of senior members of the team. The position… more
- Parexel (Indianapolis, IN)
- …Clinical Quality Monitoring of critical data . Support close to real time clinical data Ongoing medical review with transparent documentation of the ... questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan , laboratory parameters specifications for the project, … more
- Stony Brook University (Stony Brook, NY)
- …efforts in the Department of Emergency Medicine as per the following duties: + Review all active protocols, manage clinical trials from IRB initiation to ... review of patient's medical records. + Responsible for data collection for study analysis. + Ensure that treatments,...per protocol. + Identify candidates to be enrolled in clinical trials, review present protocol patients for… more
- Parexel (Tallahassee, FL)
- …include one or more of the following: development of tools and dashboards for sample/ data tracking, review of clinical sample collection, resolving sample/ ... integrity and completeness for database locks. - Use technical tools/ systems and programming languages to systematically clean data...- Maintain and review metrics related to clinical study samples, data , kits, and logistics.… more
- Terumo Medical Corporation (New York, NY)
- …internal and external customers. + Ability to present and effectively communicate complex clinical and technical data to others of a non-scientific orientation ... Field Clinical Specialist, Imaging - New York City Date:...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Stanford Health Care (Palo Alto, CA)
- …**This is a Stanford Health Care job.** **A Brief Overview** The Clinical Documentation Integrity (CDI) Service Line Outcomes Lead is responsible for partnering ... peers, coding, CDI leadership and quality partners, as necessary. + Coordinates data collection and analysis, in collaboration with quality teams, related to patient… more
- Stanford Health Care (Palo Alto, CA)
- …and underpayments. Proficiency in healthcare claims analysis, including the ability to review , interpret, and evaluate claims data to identify trends, ... 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
