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
- ...NJ seeks an Associate Director - Data Standards to lead a team specializing in clinical data standards. This hybrid role involves... ...industry regulations, managing CDISC-related metadata, and contributing... ...in areas such as CDASH and SDTM. AbbVie offers a competitive salary...Data
- ...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
- Job Title Manager, Clinical Data Standards Location Basking Ridge, NJ 07920 Duration... ...of edit checks) SDTM clinical data standards Job... ...ensuring alignment with industry (CDISC) standards for Health... ...should be a subject matter expert in clinical data standards as...DataContract workWork experience placementLocal area
- AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to proactively develop data and reporting... ...trials and ensure conformance to CDISC standards and industry best... ...with cross-functional SMEs and leading SDTM/ADaM development and trial data submissions...Data
- A leading clinical research organization located in Basking Ridge, NJ is looking for a Manager for Clinical Data Standards. The role involves developing and sustaining global clinical data... ...understanding of the RAVE system and SDTM. A hybrid in-office presence is expected...DataWork at office
$141.5k - $268.5k
Associate Director - Data Standards (Hybrid) Full-time Salary... ...of data standards experts to develop, implement... ...understanding of all CDISC guidance documents and... ...understanding of CDASH and SDTM standards and concepts... ...an understanding of clinical data standards...DataFull timeLocal area- IQVIA is seeking a Clinical Data Standards Specialist to drive global data standards development and governance. You will oversee SDTM mappings, library objects in Medidata Rave, and collaborate... ...communication, and deep knowledge of CDISC standards, CRF design, and SDLC. You...Data
- ABBVIE in Florham Park, NJ, seeks a professional to enhance data standards and system designs within Clinical Data Strategy. This role requires a Bachelor’s degree with at least 5 years of hands-on EDC study build experience, particularly in Medidata RAVE. Responsibilities...Data
- AbbVie is seeking a senior clinical development leader to design and drive complex clinical programs across therapeutic areas. You will oversee investigators, ensure data integrity, and coordinate regulatory submissions with global teams. The role requires MD/DO with substantial...Data
- Novartis Group of Companies seeks a senior leader to head Clinical Development AI & Technology, defining end-to-end strategy across data, platforms, and AI—driving scalable solutions in a regulated environment. You will influence senior leadership, build global teams, and...Data
- Lead, R&D Document Standards & Integrated Services Location: Morristown, NJ / Cambridge, MA... ...across various functions within R&D including clinical, non‑clinical, pharmacovigilance,... ...analytical skills with the ability to translate data into actionable insights. Adaptability...DataWork at office
- ...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
- ...Write nonclinical summaries for clinical Investigator Brochures, INDs,... .... Ensure high scientific standards in conducting and reporting of... ...toxicity studies and data (preferred). Provide internal... ...nonclinical safety issues on various expert groups or internal committees...DataContract workWork experience placement
- ...Technology (HRT Lead) to serve as the functional and configuration expert within Oracle Cloud HCM, focusing on Core HR mastery and end-to-end module integration. You will own hands-on configuration, data integrity, and cross-module alignment to optimize the employee...Data
- Allergan is seeking a qualified candidate for a key role in Clinical Data Strategy. The position involves designing and delivering clinical trial systems, ensuring compliance with federal regulations. The ideal candidate will have a Bachelor's degree and over 5 years of...Data
$120k - $165k
...team in New Jersey. This role offers the opportunity to influence clinical development programs across various therapeutic areas. The... ..., and work closely with cross-functional stakeholders to ensure data-driven decision-making. The position offers a competitive salary...Data- ...include coordinating quality improvement initiatives, overseeing clinical registry data, and analyzing performance metrics. The ideal candidate... ...us to drive patient care improvements and ensure compliance with healthcare standards. #J-18808-Ljbffr Atlantic Health SystemData
- 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
- ...Title Global Head of Clinical Data and Business Strategy... ...is a pivotal business leader who will drive our clinical... ...compliance Drive standardization and innovation in clinical... ...design aligned with CDISC standards and... ...and CDISC standards (SDTM, ADaM, CDASH) Deep understanding...Data
- ...Description Purpose: AbbVie Data Science is the best-in-class team... ...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...DataTemporary workLocal area
- ...senior statistician to serve as lead statistician for one or more clinical development programs. You will collaborate with clinical teams... ...studies across all phases, ensuring quality of statistical design and data reporting. You will interact with regulators, external vendors,...Data
- Novartis Group of Companies in East Hanover, NJ is seeking a senior QA leader to oversee development, research, and clinical safety systems to ensure compliance with health authorities and internal standards. The role requires driving a culture of quality across global...
$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‑...DataRelocation package$22.25 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,... ...for scheduled shifts, setting the standard for the team and ensuring...DataHourly payFull timeFlexible hoursShift workAfternoon shiftEarly shift$93.8k - $174.2k
.../ maintenance perspective and help with data for timely closure of deviations and CAPAs... ...oversight as local process Subject Matter Expert (SME). Continuously develops personal and... ...Performance Indicators Highest safety standard implemented during projects and operations...DataWork at officeLocal areaVisa sponsorshipRelocation package- ...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...Data
$350k
...of these services report up to the Chief Clinical officer and work together... ...staff will be required to meet the high standards of healthcare in accordance with policies... ...Center. Requirements: * Strong clinical leader with experience driving improvements in...Full timeLocal area$152.63k - $254.38k
...and Maine. The Thought Leader Liaison (TLL) builds... ...group of U.S. external experts within assigned therapeutic... ..., and synthesize clinical, competitive, and strategic... ...qualitative and quantitative data available from Insights... ...and compliance standards with proactive risk identification...DataLocal areaNight shift- 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...
- ...an experienced Director-level Clinical Data Management Consultant to... ...collection from CRO). Oversee SDTM configuration and formatting... ...regulatory data specifications. Standardize study monitoring reports and... ...Data Capture systems. Advanced CDISC SDTM and ADaM knowledge. SAS...DataFull timeContract work
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