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
- ...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
- 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
- ...program-building. The position offers protected leadership time and the opportunity to shape clinical standards, oversee documentation, and develop the team as it grows. NJPCS emphasizes data-guided mentorship and collaboration. #J-18808-Ljbffr NJ Palliative Care SolutionsData
$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- 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
- AbbVie is seeking a physician leader to oversee the direction, planning, execution, and interpretation of clinical trials within one or more development programs. The role requires... ...of study design, enrollment, safety data, and regulatory submissions. You will provide...Data
- ...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
$121.4k - $338.4k
...Product Management to lead a portfolio of data-driven personalization products within... ...Analytics Innovation• Translate IQVIA’s clinical, behavioral, and engagement data into productized... ...meet privacy, compliance, and consent standards critical to healthcare data usage._______...DataFull timePart timeImmediate startRemote workWork from homeWorldwide- ...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
- ...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
$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- ...Role Overview Turing invites Legal Experts to join projects that fine-tune AI models like... ...and project managers to align evaluation standards and project goals. Requirements ~ Juris... ...frontier research with high-quality data, advanced training pipelines, plus top AI...DataFreelanceRemote workFlexible hours
- 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
- ...to oversee the direction, planning, execution, and interpretation of clinical trials within one or more development programs. You will participate in cross-functional teams to generate high-quality data supporting product strategy. You will supervise study design, data...Data
$318.5k
..., and unbossed medical leader can leave a lasting imprint... ..., you will shape standards of care, advance access... ...support reimbursement and clinical adoption. Expand the... ...relationships with medical experts and professional... ...Collaboration, Cystic Fibrosis, Data Entry, Diversity &...DataRemote workRelocationVisa sponsorshipRelocation package- AbbVie currently seeks a data systems professional to advance clinical trial information management. You will design... ...EDC solutions, driving data standards and ensuring regulatory compliance... ...Medidata RAVE experience, strong CDASH/SDTM knowledge, and the ability to...Data
- ...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 Companies is seeking a Senior Clinical Research Associate (Sr. CRA) who will manage site relationships and perform monitoring... ...trial execution and ensuring compliance with regulatory standards. The ideal candidate will have clinical site monitoring...Remote job
- Atlantic Health, Inc. in Morristown, NJ is seeking a Clinical Nutrition Specialist (CNSC) to perform clinical nutrition activities in... ...participate in education and quality assurance to meet regulatory standards. On-site hospital role with opportunities to contribute to...
- ...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
$119.7k - $222.3k
...deliverables while meeting internal quality and data integrity requirements Implement... ...contribute to analytical development for clinical and commercial manufacturing and assist in... ...assigned. What you will bring to the role For Expert level: Bachelor's degree in biology,...DataLocal areaRelocation packageFlexible hours$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- Atlantic Health is seeking a Nurse Manager for Clinical Operations in New Jersey. This role leads a team to ensure efficient patient flow, engages in capacity planning, and collaborates with site leadership to optimize operations across the system. The position requires...
$117.4k - $327k
...supportability, and enterprise architecture standards.• Lead discovery and intake activities with sales leaders, commercial operations,... ..., process consistency, data quality, and platform adoption.... ...is a leading global provider of clinical research services, commercial insights...DataFull timePart timeImmediate startWorldwide- Jobtailor seeks an experienced field-based orthopedic support specialist to guide surgeons in the operating room and provide expert clinical and technical assistance. You will ensure proper equipment is available, functioning, and ready for procedures in a fast-paced setting...
- 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...
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