Clinical Data Standards Leader - CDISC/SDTM Expert
AbbVie
AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive data and reporting standards for clinical trials and ensure conformance to CDISC standards. You will lead SDTM/ADaM development, define standards, document decisions, and coordinate across therapeutic areas to support regulatory submissions. Responsibilities include SDTM programming, defining datasets, and creating guides for FDA/PMDA submissions, while advancing training and communication across the #J-18808-Ljbffr AbbVie
- ...Description The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates... ...AbbVie’s conformance to CDISC standards and industry... ...as well as pipeline‑based SDTM development. This role implements... ...team of subject matter experts to define one more of the...Data
- ...modules in line with program standards.Responsible to support development... ...implementation of relevant data capture tools in... ...performing the ongoing review of clinical trial data as outlined in the... ...streams or act as Subject Matter Experts for training or SOPMay support...DataContract workWork experience placementWork at officeImmediate start
$120.2k - $140k
...? As an experienced Clinical Data AMS Senior Consultant... ...and operational expert for the Clinical Data... ...with global regulatory standards (GxP, 21 CFR Part 11... ...Experience with CDISC standards (SDTM/ADaM) as they relate... ...employees to senior leaders, we believe there’s...DataPermanent employmentLocal areaRemote workVisa sponsorship- ...manage and develop a group of data standards experts to develop, implement and... ...-depth understanding of all CDISC guidance documents and implementation... ...understanding of CDASH and SDTM standards and concepts. Able... ...an understanding of clinical data standards concepts, clinical...DataFull timeLocal area
$93.8k - $174.2k
...bedside! This exciting role serves as an Expert Science & Technology to develop,... ...while maintaining the highest quality and data integrity standards. This individual will uphold Novartis... ...lab management including inventorying, clinical sample cryopreservation, sample...DataFull timeVisa sponsorshipRelocation package- ...company is seeking a Principal Biostatistician to provide expert statistical support for clinical development and research projects. The role involves... ...decision making and ensuring compliance with industry standards. Candidates should have a PhD or MS with significant experience...Data
- Sanofi is seeking a Clinical Scientist in ophthalmology to support medical supervision of ophthalmology clinical studies under the Clinical... ...Research Directors. The role involves medical review of study data, protocol validation, and literature analysis to advance retinal...Data
$108.5k - $201.5k
...project timelines and deliverables while meeting internal quality and data integrity requirements Implement resolution to technical... ...regulatory filings Actively contribute to analytical development for clinical and commercial manufacturing and assist in advancing science-...DataFull timeRelocation package- ...Description Purpose: AbbVie Data Science is the best-in-class... ...generate business value from clinical trials data. Our operational... ...the development of common data standards and ensures systems designs comply... ...of CDASH (Required) and SDTM. •Demonstrated performance as...DataFull timeTemporary workLocal area
- AbbVie is seeking an experienced data systems professional to lead design and delivery of clinical data systems. You will ensure standards compliance, drive end-to-end EDC/IRT/ePRO integrations... ...; Veeva EDC a plus. Strong CDASH/SDTM knowledge and excellent communication...Data
- ...project delivery, including clinical trial reports and other regulatory... .... Assist in establishing standardized programming procedures and work... ...(e.g., biostatisticians, data managers, medical writers, etc... ...agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards). Assist...DataRemote work
$24 per hour
...readers and the community. As Café Team Expert (CTE), you are an integral leader for the café team. You work through... ...good at identifying and connecting data, using it to impact sales, trends,... ...hold you, and themselves, to high standards, and for your Store Managers to...DataHourly payFull timeFlexible hoursShift workAfternoon shiftEarly shift- ...single cases. Performs signal detection monitoring and evaluation based on single cases, aggregate data and signal detection tools, i.e. EMPIRICAPrepares clinical expert statements and provides input in responses to inquiries from regulatory authorities or healthcare professionals...DataImmediate start
- ...line functions, post marketing data, and other sources.3.... ...searches, literature review, expert statements.10. Coordinates involvement... ...activities of Pharmacovigilance Leader such as ad-hoc medical case... ...safetyo Experience in preparing clinical safety assessments, risk/benefit...DataWork at officeImmediate start
$91.71k - $156.49k
...works closely with Project Managers and Team Leaders to support inspection program delivery,... ...recommendations.The Engineer III applies standard engineering techniques, procedures, and... ...continuous improvement of inspection and data management processes.As part of the team,...DataFull timeLocal areaImmediate startVisa sponsorship- Med-Metrix, LLC is seeking a Clinical Documentation Integrity Specialist to ensure accurate inpatient documentation for proper coding and reporting. You will perform concurrent chart reviews, validate severity of illness and risk of mortality, and collaborate with physicians...
$86.6k
...casualty, accident & health, specialty and standard commercial lines insurance solutions. A... ...Operations LeaderThe Construction Operations Leader drives operational performance for the... ...cost, quality, speed, service, and data integrity while ensuring the team and operating...DataFlexible hours$114.5k - $188.9k
...the Lead, Information Security Library & Standards, you will help build the foundation that... ...Risk Management and Information Security leaders to establish a scalable control library,... ...Defense & Response (CDR), cloud security, data protection, vulnerability management, and...DataFull timePart timeWork at officeRemote work3 days per week$105.59k - $180.17k
...compliance with project requirements and safety standards. This role includes planning and... ...project manager to ensure all inspection data is accurately recorded and submitted on schedule... ...support staff such as (Assistant Team Leaders and CADD techs).Lead a small team of...DataLocal area$91.71k - $156.49k
...works closely with Project Managers and Team Leaders to support inspection program delivery,... .... The Engineer III applies standard engineering techniques, procedures, and criteria... ...continuous improvement of inspection and data management processes. As part of the team...DataFull timePart timeFor contractorsWork at officeLocal areaImmediate startVisa sponsorship$84.6k - $211.6k
...SystemsDesigns or modifies data models to solve complex... ...Essential FunctionsClinical Data Standards & Operational... ...and maintenance of global clinical data standards, including... ...Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology,...DataFull timeContract workPart timeImmediate startWorldwide$77k - $202k
...SummaryThe OpportunityAs a Test Execution Leader within our Banking and Capital Markets... ...it is evolving. Your ability to interpret data will inform insights and recommendations, reinforcing professional and technical standards. This position offers a unique opportunity...DataFull timeH1b- ...positions for contract research in Clinical trials of drugs, biologics and... ...projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates... ...quality checks for clinical study raw data and report the findings to Data...DataContract workImmediate start
- ...teams, implement theft-deterrence strategies, and maintain safe club operations while enforcing company standards. The role emphasizes leading through change, using data to drive results, and building strong, collaborative teams that protect assets and maintain stock...Data
- ...review programming requirements, and ensure quality control per CDISC standards. Strong leadership and ADaM/TFL experience are essential. You... ..., risks, and documentation while upholding regulatory expectations and data integrity. #J-18808-Ljbffr Scorpion TherapeuticsData
- Sanofi Inc. in the U.S. seeks an Enterprise Data Strategy Lead to drive a multi-year data... ...lead Agile, matrixed teams shaping data standards that inform brand and medical strategy,... ...responsibilities, partnering with senior leaders to translate complex data needs into actionable...DataLocal area
- ...Health Care in Livingston, NJ, is seeking a Registered Nurse (RN) Clinical Manager to lead our Assistive Care team. You will guide a high... ...partner with families and referral sources to maintain high standards of service while upholding BAYADA policies and state #J-18808...Full time
- ...Assurance (QA) is responsible for supporting clinical and commercial product quality through QA... ..., QC and environmental monitoring data, donor eligibility records, and other quality... ...regulations, and Celularity quality standards. Role & Responsibilities Conducts...DataRelocation
$55k - $60k
...Team Leader Call Center Come join us as a Team Leader of our Call Center in Parsippany... ...healthcare related call center and managing standard call center metrics. In addition, we seek... .... Prepares reports and analyzes data to assist in determining call center goals...DataFull timeWork experience placementWork at officeHome officeMonday to Friday1 day per week- ...Job Description AbbVie Data Science is the best-in-class team... ...generate business value from clinical trials data. Our operational model... ...designs and that common data standards are used Ensures that... ...process Knowledge of CDASH and SDTM Demonstrated ability to influence...DataFull timeTemporary workLocal area
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