8,676 Clinical Standards jobs in India

Principal Clinical Data Standards Consultant _ Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Join ICON as a Principal Clinical Data Standards Consultant!
Are you an expert in SDTM standards with specific proficiency in R and SAS programming? ICON is seeking a talented individual to support the development and implementation of SDTM standards internally and for our esteemed sponsors.
**Job Summary:**
+ Develop and implement ICON's standards libraries for SDTM mappings, including creating tools and macros to facilitate implementation.
+ Provide consulting services internally and externally on SDTM compliance and implementation.
+ Assist sponsors in developing, implementing, maintaining, and governing data standards content.
+ Support the development and upkeep of technologies used for SDTM standards implementation.
+ Participate in standards governance team meetings and offer standards input as required.
**Requirements:**
+ Expert knowledge of SDTM, SDTM Implementation Guides, and Controlled Terminology.
+ Proficiency in R and SAS programming, with familiarity in other languages.
+ Ability to apply business expertise to address challenges and recommend best practices for product and service enhancement.
+ Willingness to travel occasionally (less than 5%).
+ Leadership skills to contribute to departmental initiatives, possibly leading projects and mentoring junior team members.
+ 10-15 years of relevant experience.
+ Strong problem-solving abilities and the capacity to impact operational and departmental objectives significantly.
+ Excellent interpersonal skills to adapt communication style, persuade effectively, and present complex analyses.
If you are ready to make a substantial impact in the field of SDTM standards and contribute to cutting-edge projects at ICON, apply now to join our dynamic team!
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply

Principal Clinical Data Standards Consultant _ Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Are you an expert with practical experience in CDISC and CDASH standards?
Do you have build/design experience in Medidata Rave EDC and/or Veeva Clinical Data (Vault CDMS/EDC)?
If so, join our diverse and dynamic team at ICON as a Principal Clinical Data Standards Consultant! As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in the development and implementation of forms for the ICON Standards team internally and for our esteemed sponsors.
**Job Summary**
As a Principal Clinical Data Standards Consultant at ICON Plc, you will be responsible for:
+ Developing and implementing ICON's standards libraries in compliance with CDISC, Sponsor, and ICON standards.
+ Managing the development and maintenance of data management processes and tools.
+ Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
+ Participating in standards governance team meetings and offering standards input as required.
+ Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Controlled Terminology, ADaM, define-XML and regulatory submission requirements.
+ Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.
**Requirements**
To excel in this role, you should possess the following qualifications and attributes:
+ A Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus.
+ Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
+ Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).
+ Excellent analytical and problem-solving skills with keen attention to detail.
+ Excellent interpersonal skills, communication and collaboration abilities to work effectively in cross-functional teams.
+ Strong problem-solving abilities and the capacity to impact operational and departmental objectives significantly.
If you are ready to make a substantial impact in the field of CDASH standards and contribute to cutting-edge projects at ICON, apply now to join our dynamic team!
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply

Job Description Summary

The Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.
They provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including;
• Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications
• Analysis data/TFL standards
• Associated standard metadata, business rules and guidelines.

 

Job Description

1. Lead and contribute to Clinical Data Standards definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.

2. Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
3. Responsible for driving the efficient, high quality and timely implementation of new standards and/or updates to standards for: Data Acquisition and Tabulation standards
• Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
• Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).
• Use advanced database programming techniques to support the implementation of efficient data collection tools.
• Processes, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission.

4. In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards.
5. Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
6. Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.
7. Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.
8. Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.

9. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems

10. Act as subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.
11. Provide mentoring and technical guidance to Clinical Data Standards associates.
12. Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
13. May represent Novartis within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
14. As needed, act as a Clinical Standards representative supporting data standards governance, process improvement initiatives and/or other non-clinical projects.

 

Skills Desired

Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis

Job Description Summary

The Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.
They provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including;

• Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications

• Analysis data/TFL standards

• Associated standard metadata, business rules and guidelines.

Job Description

1. Lead and contribute to Clinical Data Standards definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.

2. Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
3. Responsible for driving the efficient, high quality and timely implementation of new standards and/or updates to standards for: Data Acquisition and Tabulation standards

• Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation

• Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).

• Use advanced database programming techniques to support the implementation of efficient data collection tools.

• Processes, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission.

4. In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards.
5. Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
6. Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.
7. Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.
8. Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.

9. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems

10. Act as subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.
11. Provide mentoring and technical guidance to Clinical Data Standards associates.
12. Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
13. May represent Novartis within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
14. As needed, act as a Clinical Standards representative supporting data standards governance, process improvement initiatives and/or other non-clinical projects.

Skills Desired

Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis

Job Opportunity

The Principal Clinical Data Standards Specialist is responsible for the development, maintenance, and implementation of Industry-compliant Clinical Data Standards. They provide expert support to business users and teams on their use in line with the Clinical Data Standards strategy.
Key responsibilities include ensuring timely availability of consistent, high-quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including;

• Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications

• Analysis data/TFL standards

• Associated standard metadata, business rules, and guidelines.

Required Skills and Qualifications

• Expertise in clinical data standards development and maintenance
• Strong analytical and problem-solving skills
• Ability to work collaboratively with cross-functional teams
• Excellent communication and interpersonal skills

Benefits

• Opportunity to work on a high-impact project with a dynamic team
• Professional growth and development opportunities
• Competitive compensation and benefits package

Others

• Collaborative and dynamic work environment
• Flexible work arrangements
• Recognition and rewards for outstanding performance

Are you passionate to improve Quality of highly scalable distributed software systems for International Seller Growth tech team, come join us in this exciting journey.

Key job responsibilities

• Design and execute systems to check for issues
• 
  
• Document test cases
• 
  
• Perform and document risk analysis
• 
  
• Record test progress and results
• 
  
• Code automated tests
• 
  
• Create test plans
• 
  
• Develop standards and procedures to determine product quality and release readiness
• 
  
• Discover bugs within software
• 
  
• Drive innovation and streamline overall testing processes
• 
  
• Identify, isolate, and track bugs throughout testing
• 
  
• Identify any potential problems that users might encounter
• 
  
• Perform manual and automated testing
• 
  
• Research and analyze product features being tested
• 
  
• Research new tools, technologies, and testing processes
• 
  
• Review user interfaces for consistency and functionality

About The Team

The International Seller Growth Team's mission is to set our worldwide Sellers up for success across our global Marketplaces. We deliver needle-moving initiatives which provide a seamless experience to Amazon Sellers at each step of the Seller journey. We enable Sellers across the world to list millions of products at scale across multiple categories and dozens of languages in our global Marketplaces. This includes automatically mapping Seller product information to the Amazon namespace and automating complex decision making (like Product Classification in our Catalog) on the Seller's behalf. We provide Sellers with strategic selling recommendations based on hybrid demand signals (like high-value products they should start selling in additional Marketplaces). We partner with Amazon Business to build best-in-class solutions that allow B2B Sellers to reach a wide customer base and drive billions of dollars in revenue. We continuously improve the state of the existing catalog created by Amazon Sellers through smart solutions that automatically identify and fix defects using self-learning heuristics leveraging textual and image-based signals

Basic Qualifications

• Minimum 1+ years of experience
• Bachelors degree
• Manual testing experience (UI, API, DB)
• Automation and coding/scripting knowledge
• 
  

Preferred Qualifications

• Automation framework knowledge

Skills Required
Scripting, Coding, Automation Framework

• Design, develop, integrate (preferably Python).
• Design, develop, and integrate a highly automated system and solutions testing environment for private and public cloud environments.
• Knowledge of quality assurance terminology, 4G/5G Networking testing, methods, and tools
• Detailed understanding of SDN, NFV, and VMware Virtualization technologies.
• Understanding the CMMI ( Capability Maturity Model Integrated) and TMM (Test Maturity model)
• Demonstrated knowledge of testing best practices, version control practices, and defect management practice
• Proficient in developing pipeline code with one of the CI/CD/CT tool such as GitLab CI, Jenkins
• Experience with 5G Service Based Architecture, Call flows
• Knowledge of security is a plus.
• Knowledge with NFV SDN Standard Architecture

Job Description

Review the product releases.

Test current software products and identify deficiencies.

Suggest solutions to identified product problems.

Work on tools, concepts, and methodologies of QA.

Solid experience ineffective usage of data analysis tools and statistical analysis.

Writing and reviewing testing plans.

Work on other initiatives to improve the product.

Requirements

MS-Word, MS-Excel.

Eye for detail.

Knowledge of bug reporting tools like JIRA and REDMINE.

Data collection, management, and analysis.

Problem analysis and problem-solving.

Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma.

About Company / Benefits

StarClinch offers the thrill of working with a young team, the ability to make an immediate impact, and the opportunity to work with a game-changing product that is disrupting the live entertainment business forever. In simple words, StarClinch is India's largest artist booking and discovery platform. We own and execute the entire process from artist shortlist, availability check, negotiation, booking, payment, and escrow.

Our extensive list of models, dance troupe, live bands, photographers, instrumentalists, singers, and performers, serves as a tool to find the best of talents, well suited for any gathering. Our aim is to bridge the gap between a host and an artist, through a secure, cost-effective, and transparent medium, for a successful collaboration. Our office is located inDLF Commercial Centre, Greater Kailash .

Perks:

Laptop to work from home

Health + Accidental Insurance 

Free Doctor Consultations

Exposure to how things work in a startup

The extensive learning curve in the field

Informal dress code

Flexible working hours

Premium Office and workspace

Key Competencies:

• Strong attention to detail with a keen eye for identifying defects and inconsistencies
• Manual Testing expertise across platforms
• Cross-browser compatibility testing on mobile, tablet, and desktop environments
• Hands-on experience with mobile application testing (mandatory)
• Exposure to native iOS and Android app testing
• Familiarity with HTML5 banner testing
• Excellent verbal and written communication skills
• Strong data collection, management, and analysis capabilities
• Problem analysis and problem-solving aptitude
• Effective in planning and organizing tasks independently
• Strong customer service orientation and stakeholder engagement
• A collaborative mindset with excellent teamwork skills

Tools & Platforms:

• JIRA (Atlassian)
• Asana
• TestRail
• Knowledge of additional bug tracking or test management tools is a plus

Main Job Tasks & Responsibilities:

• Draft and maintain quality assurance policies and procedures
• Interpret and implement QA standards across testing workflows
• Evaluate the adequacy of QA standards and suggest improvements
• Devise sampling procedures and methods for recording/reporting quality data
• Review the implementation and efficiency of quality and inspection systems
• Plan, conduct, and monitor testing and inspection of products/materials to ensure compliance with quality standards
• Document internal audits and other QA activities
• Investigate customer complaints and non-conformance issues
• Collect and compile statistical quality data
• Analyze QA data to identify areas of improvement in the quality system
• Develop, recommend, and monitor corrective and preventive actions (CAPA)
• Prepare comprehensive quality reports for internal and external communication
• Monitor and support risk management activities
• Manage and maintain document control systems

Education & Experience:

• Bachelor's degree (preferred in Engineering, Computer Science, or related field)
• Certifications are a plus:
• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)
• Six Sigma , Quality Improvement Associate , etc.
• Experience in quality inspection, auditing, and software testing
• Strong computer skills, including Microsoft Office and database management
• Knowledge of QA methodologies, tools, and concepts
• Familiarity with relevant regulatory and compliance standards

Skills Required
Manual Testing, Html5, Problem Analysis, Asana