18 Cdash Jobs

About The Job Title: Principal Data Standards Analyst (Laboratory Expert) Level : L2-2 The Principal Data Standards Analyst (Laboratory Expert) plays a crucial role in ensuring the accurate standardization, integration, and management of laboratory data across clinical studies. This role supports Clinical Information Governance (CIG), Trial Operations (TO) , Data integration, Translational Medicine, Sample Management, and external vendors, ensuring compliance with CDISC standards (SDTM, CDASH, Controlled Terminology) and regulatory requirements. The Principal Data Standards Analyst (Laboratory Expert) also provides specialized oversight on laboratory data handling, collaborating with interna...

Role Overview: At EY, you will have the opportunity to shape a unique career tailored to your strengths, with the necessary global support, inclusive environment, and advanced technology to help you reach your full potential. Your distinct voice and perspective are crucial in contributing to EY's continuous improvement. By joining us, you will not only create a remarkable experience for yourself but also contribute to building a better working world for all. Key Responsibilities: - Drive consulting engagements focused on clinical data transformation, including SDTM mapping, CDASH adoption, and standards harmonization. - Lead client workshops, diagnostic assessments, and solution design initi...

Job Overview The RN Associate / Senior Associate, Clinical Data Management is responsible for delivering and overseeing clinical and patient reported data within electronic data capture (EDC) platforms, including iTakeControl. Activities include monitoring databases and video evidence, maintaining data quality, and database integrity for research studies from conception to closeout. The role will work closely with the Clinical Operations, Product Management and Technical Delivery teams and is responsible for detailed specification development, documentation, and supporting clinical operations, project management and delivery activities for Clinical and iTakeControl (iTC) product client proje...

Lead clinical study data management from setup to closeout, ensuring quality, compliance & timelines. Manage teams, vendors & stakeholders, resolve data issues, oversee CRFs, UAT, coding, validation & database lock for regulatory submission.

As a Data Standards Specialist at ICON plc, you will be responsible for creating and maintaining content in the Data Standards Catalog. You will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your role will involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Additionally, you will actively participate in governance team meetings and provide input on assigned standards. You will work closely with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy and ensure compl...

As a Clinical Database Programmer at our rapidly growing global organization, you will be an integral part of our Biometrics team, working collaboratively in a team setting to contribute to the success of the company. If you are looking for a dynamic career opportunity where you can leverage your expertise and further develop your skills, this position is perfect for you. **Responsibilities:** - Develop, program, validate, and maintain clinical trial databases following company standards - Maintain and enhance the company library of standard CDASH compliant CRFs - Serve as the primary point of contact for the data management team for assigned studies, offering necessary technical support, en...

As a Project Manager in Clinical Data Management at SyMetric, your role involves handling customer projects independently with minimal supervision. Your responsibilities include: - Managing projects related to Clinical Data Management, including systems and services for IWRS/EDC/CTMS - Customer management for assigned projects - Monitoring project timelines and taking necessary actions to ensure projects stay on track - Ensuring all project deliverables are met for customer satisfaction - Serving as the primary point of contact from SyMetric Additionally, you will provide clinical data management support to the Clinical Operation Team, Sponsor, Customer, and Clinical Data Management Team. Yo...

As an Implementation Consultant reporting to the Product Owner, your key responsibilities will include creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. You will be tasked with developing wireframes and mock-ups for clinical reports, as well as communicating with Clinical Data Management & Medical Reviewers to document clinical reporting needs. It is essential that you stay up-to-date with all Saama product features and releases. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will act as a Clinical Subject Matter Expert, providing support for...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As a Manager in Clinical Data & Technology within Life Sciences Consulting at EY, you will be part of our Life Sciences sector team, assisting clients in reimagining their clinical data strategies and implementing cutting-edge solutions across trial data capture, management, and analytics. You will play a strategic role in shaping next-gener...

As a Data Management Specialist, you will be responsible for designing and reviewing Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. You will develop and maintain Data Management Plans (DMPs), data validation specifications, edit checks, and coding guidelines. Your role will involve overseeing data entry, data cleaning, discrepancy management, and query resolution processes to ensure data integrity. It will be your responsibility to ensure compliance with industry standards such as CDISC (CDASH, SDTM) and regulatory guidelines from FDA and ICH-GCP. You will be involved in conducting User Acceptance Testing (UAT) of EDC systems and monitoring data quality throughout the pr...

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas su...

JOB Description: Testing Engineer About Us: Inductive Quotient was founded by statisticians and technology industry experts with over 20 years of experience Inductive quotient aims to transform businesses and processes with its advanced digitization capabilities. With advanced AI and Machine Learning techniques we are helping Life Sciences industry to create a better healthcare system, and our Data Science capabilities helps organizations to create breakthrough solutions to transform businesses and drive sales growth. Website: www.inductivequotient.com We are seeking a skilled EDC Tester to validate the functionality, usability, compliance, and performance of our clinical EDC platform. You w...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the...

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned ...

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, you will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Collaborating with Senior/Princ...

As a Senior Clinical Data Analyst, you will be responsible for creating Data Management Plans (DMP), eCasebook Guidelines (eCCGs), Edit Check Specifications, Data Review Listing Specifications, and other set-up documents. You will also perform User Acceptance Testing (UAT) and review the Electronic Data Capture (EDC) database to ensure data consistency and completeness. Your duties will include Listings Review, Query Management, managing Serious Adverse Events (SAE) and external vendor data reconciliation, analyzing data trends, and generating reports. Additionally, you will be involved in User Account Management, Study Metrics, Quality Control (QC), and EDC Archival. In the role of Senior S...

We're looking for an experienced professional to join our team in Hyderabad, accountable for the setup and maintenance of External Data Streams within assigned clinical trials. You'll ensure these streams adhere to best practices and defined guidelines, contributing to the integrity and efficiency of our clinical data. Key Responsibilities Accountable for the setup and maintenance of External Data Streams within assigned trial(s) according to best practices and defined guidelines. External Data Streams include, but are not limited to, ePRO, eSource, EHR, Real World data , and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS). Your activities and deli...