9,110 Clinical Governance 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

Job description

JD RMS EXECUTIVE

 Roles and responsibilities

 :
· Cross checking BOD for All segments before Market Start.
· Making Activation and Deactivation of Trading Terminal and Investor client. 

· Ability to resolve queries on a day to day basis.
·

 Keeping Monitoring on Additional Surveillance Margin (ASM) and reporting to HOD. 

· Blocking GSM and Illiquid scrip on Time to Time in the Trading system.
·

 RMS Blocking for Debit, RMS Blocking for Far month Contract, RMS Blocking for
Illiquid scrip. 

· Keeping track of MTM Alert violation, MTM net position & Square off the open position
once MTM Loss get triggered.

 · Responsible for squaring off all the intraday position through Timer Square off for all
segments.

 · Supervision of Limit assigned to the clients (Base Limit and Intraday limits). 

· Coordination with different teams. 

· Surveillance of Script Wise & Client wise Position, Simulated Trade, Script concentration
etc.

 · Track on Tender period contract in all Segments, Whole process of Straggled Delivery
Mechanism.

 · Successfully Implementation Exchange & Depository Related Compliances.

 · Enhance Supervisor Reporting, Client fund, Collateral, Security Balance (Weekly's).

 · Daily Margin Reporting for all Segments.

 · Quarterly Settlement of A/Cs & Dormant & Inactive Process & CTCL Empanelment.

Roles and Responsibilities  

Tracking Market movement and Risk exposures of clients- ODIN /OMNSYS
Monitoring clients positions, limits and triggering
Exchange Margin preparing and reporting
Take follow up of Peak & MTM Margin
Knowledge products like MTF, Exchange settlement

Desired Candidate Profile  

Perks and Benefits  

**Description**
At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your career.
Here, your voice and ideas matter, your work makes an impact, and together, you will help us define the future of American Express.
**How will you make an impact in this role?**
The Fraud, Credit Bust Out (CBO), Banking Product & Payments Risk Organization is a global team of risk officers, data scientists, and product managers that are building innovative solutions and capabilities to manage external fraud and payment risk across AMEX's card and banking portfolios.
We are looking for an **Analyst** **to join the Fraud, Credit Bust Out (CBO), Banking Product & Payments Business Operations team** , which will oversee how the Global fraud team meets expectations outlined in the enterprise-wide policies and governance requirements for operational and fraud risk management across both the global card and banking product portfolios. The team will be responsible for executing new programs that govern, monitor and improve the CBO and payments' group's extensive strategy execution controls, providing thematic analysis on operational issues associated with fraud processes, and creating and maintaining CBO and payments RCSAs.
Key Responsibilities
+ Support the RCSA program through administrative tasks related to process mapping, risk and control identification, assessment, and annual review
+ Support monitoring of portfolio performance by calculating prescribed metrics and participating and documenting in root cause analysis and remediation plans
+ Support through administrative tasks the timely updates of documentation and operational controls as new customer features & fraud capabilities are introduced
+ Support the execution of BU's risk assessment through analysis and data collation
* Conduct controls testing in accordance with Internal Controls Policy
* Lead victim fraud events analysis with operational risk lens and partner with functional experts to identify and remediate gaps
* Support multiple compliance and regulatory programs, such as AML/BSA SARs referrals, elder fraud abuse detection, scams detection, etc.
* Provide administrative support to evidence collection and explanatory responses to exams, audits, and any ad hoc governance requests
* Provide administrative support to Track and identify issues and fraud events as outlined by the Issues and Events Policy
Required Qualifications
* Strong project management, communication, and interpersonal skills
* Experience in process governance, with an understanding of processes that align with policies, regulatory frameworks, and/or operational standards
* Proficient analytical and problem-solving skills, with an ability to analyze data, identify trends, and evaluate Victim fraud risk scenarios effectively
* Ability to navigate through ambiguous problems and be creative
* High degree of organization, individual initiative and personal accountability
* Positive "roll-up your sleeves" attitude, a proactive mentality, and a passion to win required
Preferred Qualifications
* Bachelor's Degree in Finance, Business, Risk Mgmt., or related field; advanced degrees (e.g., MBA, MSc) or certifications are advantageous
* Understanding of critical operational risk management lifecycle activities
* GSIB Operational Risk or RCSA program experience
* Experience managing operational risk events
* Prior fraud experience
GUARDIAN
**Qualifications**
We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally:
+ Competitive base salaries
+ Bonus incentives
+ Support for financial-well-being and retirement
+ Comprehensive medical, dental, vision, life insurance, and disability benefits (depending on location)
+ Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need
+ Generous paid parental leave policies (depending on your location)
+ Free access to global on-site wellness centers staffed with nurses and doctors (depending on location)
+ Free and confidential counseling support through our Healthy Minds program
+ Career development and training opportunities
American Express is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law.
Offer of employment with American Express is conditioned upon the successful completion of a background verification check, subject to applicable laws and regulations.
**Job:** Risk
**Primary Location:** India-Haryana-Gurugram
**Schedule** Full-time
**Req ID:** 25014959