clinical regulatory analyst Jobs

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Clinical Research Associate

OSI Engineering, Inc.

Mountain View, California, USA

Full-time

A global device company is looking for a motivated Clinical Research Associate to support studies involving wearable sensor technology and human subject data collection. Key responsibilities include executing data-collection protocols, preparing devices, coordinating study logistics, and ensuring high-quality data. If you have a background in engineering or a related field, experience with mobile sensors or wearables, and a passion for advancing health technology, we invite you to apply and joi

Clinical Data manager

Intone Networks Inc.

Remote

Contract, Third Party

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T

Clinical SAS programmer

Katalyst Healthcares and Lifesciences

Athens, Georgia, USA

Full-time

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation, review, completion, and delivery of statistical programming activities and deliverables for study projects. Perform acquisition and curation of data, including full Clinical Data Interchange Standards Consortium (CDISC) standardization and Pseudo-CDISC Standardization. Document and implement p

Clinical Business Systems Analyst - D/T NYC, onsite

Winston Staffing Service

New York, New York, USA

Contract

A clinical business analyst plays a crucial role in healthcare organizations by analyzing clinical data and operations to improve business performance and ensure regulatory compliance. Duties & Responsibilities Analyze and document business requirements and processes; communicate requirements to technical personnel through the construction of basic conceptual data, process models and flowcharts, and technical specifications.Interview end users, stakeholders, and project sponsors in order to ass

Bidirectional Clinical Data Exchange Architect

Digital Minds Technologies Inc.

Remote

Contract

Job Title: Bidirectional Clinical Data Exchange Architect Location: Durham, NC (Remote) Project Duration: 6+ Months Contract (Only W2 Contracts) Job Description: The Bidirectional Clinical Data Exchange Architect will be responsible for designing, implementing, and maintaining bidirectional clinical data exchange solutions. This role requires a deep understanding of healthcare interoperability, data exchange standards, and clinical workflows. Key Responsibilities: Architecture Design: Design and

Clinical SAS programmer

Katalyst Healthcares and Lifesciences

Boulder, Colorado, USA

Full-time

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation, review, completion, and delivery of statistical programming activities and deliverables for study projects. Perform acquisition and curation of data, including full Clinical Data Interchange Standards Consortium (CDISC) standardization and Pseudo-CDISC Standardization. Document and implement p

Clinical Data Specialist

Katalyst Healthcares and Lifesciences

Illinois, USA

Full-time

Responsibilities: Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process. You'll lead the execution of feasibility testing to de-risk data capture approaches and own the implementation of data validation checks to ensure data quality. In addition, you'll work alongside other team members on

Clinical SAS programmer

Katalyst Healthcares and Lifesciences

Lake Success, New York, USA

Full-time

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation, review, completion, and delivery of statistical programming activities and deliverables for study projects. Perform acquisition and curation of data, including full Clinical Data Interchange Standards Consortium (CDISC) standardization and Pseudo-CDISC Standardization. Document and implement p

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

Bridgewater, New Jersey, USA

Full-time

Responsibilities: Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users. Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design. Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implement

Clinical Field Service Engineer

Nityo Infotech Corporation

Boston, Massachusetts, USA

Contract

Clinical Field Service Engineer Responsibilities: Conduct comprehensive inventory of clinical devices, including radiology modalities, as part of a network migration project to ensure accurate asset tracking and seamless integration into the new infrastructure.Update configuration settings on medical devices to ensure proper functionality and connectivity during a phased, site-by-site network migration.Respond to technical support requests and helpdesk tickets in a timely manner, ensuring resolu

Sr. Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

Newark, New Jersey, USA

Full-time

Responsibilities: Perform data manipulation, analysis, and reporting of clinical trial data. Develop and maintain department/system-level macros. Create and review SDTM and ADaM specifications. Create and validate SDTM data sets. Create and validate analysis data sets. Create and validate patient profiles. Program and generate tables, figures, and listings (TFLs). Validate and document SAS programs and outputs. Fulfill ad-hoc analysis requests. Provide other services. Requirements: Ba

Clinical Data Analytics Leader

Software Guidance & Assistance

South San Francisco, California, USA

Contract

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Data Analytics Leader for a direct placement assignment with one of our premier Pharmaceutical Services clients in South San Francisco, CA. Responsibilities : The Data Analytics Leader (DAL) in Early Clinical Development (ECD) Data Intelligence team supports ECD study teams by delivering timely and high-quality analysis and real-time interactive visualizations. The DAL is an expert in data analysis and data insights, enabl

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

South San Francisco, California, USA

Full-time

Responsibilities: Performs all SAS programming required for clinical trial analysis and reporting. Ensures that activities and processes performed are conducted according to sponsor requirements. Works closely with the Biostatistics and Data Management departments on various clinical projects. Designs and/or reviews database structure. Writes edit checks from the Data Cleaning Plan (DCP) specifications. Creates derived-analysis datasets. Executes analyses specified in the Statistical Anal

Sr. Clinical SAS programmer

Katalyst Healthcares and Lifesciences

Indianapolis, Indiana, USA

Full-time

Responsibilities: Perform data manipulation, analysis, and reporting of clinical trial data. Develop and maintain department/system-level macros. Create and review SDTM and Adam specifications. Create and validate SDTM data sets. Create and validate analysis data sets. Create and validate patient profiles. Program and generate tables, figures, and listings (TFLs). Validate and document SAS programs and outputs. Fulfil ad-hoc analysis requests. Provide other services. Requirements: Bachelor's deg

Senior Consultant - Clinical Data Programming

Veeva Systems

Raleigh, North Carolina, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

Princeton, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.

Senior Clinical Outcomes Assessment (COA) Lead

Sanofi

Cambridge, Massachusetts, USA

Full-time

Job Title: Senior Clinical Outcomes Assessment (COA) Lead Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients' perspective (and other subjective perspectives) into clinica

Senior Clinical Outcomes Assessment (COA) Lead

Sanofi

Morristown, New Jersey, USA

Full-time

Job Title: Senior Clinical Outcomes Assessment (COA) Lead Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients' perspective (and other subjective perspectives) into clinica

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

San Diego, California, USA

Full-time

Responsibilities: Manage programming activities on project or study level, including managing CROs to ensure deliverables are accurate and compliant. Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, ESUB packages, and documenting production and validation programs. Apply programming skills to support statistical analysis, clinical reporting, regulatory submission

Clinical Services Project Manager

Software Guidance & Assistance

Tucson, Arizona, USA

Contract

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Services Project Manager for a contract assignment with one of our premier Pharmaceutical clients in Tucson, AZ. Responsibilities : Manages multiple clinical and lab services projects of less complex nature from initiation through contract completion. Applies project management skills and experience in delivering projects on time, within budget and with high customer satisfaction. Facilitates cross-functional interacti