1,175 Informatics Nurse jobs in India
Clinical Data Specialist
Posted 2 days ago
Job Viewed
Job Description
Provide comprehensive data management expertise to eCOA Data Management to provide efficient, quality data management products that meet customer needs. Provide support in operational eCOA Data Management activities to the eCOA Data Team Lead (DTL) or operate in a specific eCOA DM task (e.g., lead of a task on a megatrial, data reconciliation and monitoring).
Essential Functions
- Serve as Data Operations Coordinator (DOC) for several global clinical trials or serve in a leadership role to a specific data management task.
- With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead
- Provide specific eCOA or Clinical DM task or technology expertise. Manage delivery of projects through full data management process life-cycle. With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope. Provide comprehensive data management expertise (including all operations tasks ). Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA DM team.
- communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA DM and project teams. Interact with eCOA DM team members to negotiate timelines and responsibilities."
Qualifications
- Working knowledge of SAS software a plus, but not required.
Bachelor's Degree Clinical, biological or mathematical sciences, or related field, or nursing qualification Req
- 3 years of related experience including clinical trials experience in a function similar to data management. Equivalent combination of education, training and experience.
- Thorough knowledge of the data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III). Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Thorough knowledge of the data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III). Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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Clinical Data Manager
Posted 2 days ago
Job Viewed
Job Description
Role : Associate Manager - Clinical Data Management
Location : Chennai, Tamil Nadu
Experience : 10+ Years
Requirements:
- 10-12 years of experience in clinical trial/data management and data operations.
- Minimum 4-5 years of people management (preferred) experience with proven supervisory
- skills.
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
- Strong background in EDC systems management and clinical data operations.
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple
- therapeutic areas.
Technical Expertise
- CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
- Deep knowledge of EDC platforms and system integrations.
- Strong understanding of regulatory requirements (HIPPA, FDA, EMA, ICH-GCP).
- Experience with electronic systems validation and 21 CFR Part 11 compliance.
Clinical Data Cordinator
Posted 2 days ago
Job Viewed
Job Description
Key Accountabilities
* Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories:
Data Review
* Performs data review of clinical trial data, including query management
* Performs reconciliation review of external data against EDC data
* May assist in creating study documents or assist in running study reports and metrics
* Performs additional review activities for interim and final database locks as needed.
Documentation & Filing
* Files study documentation in electronic Trial Master File (eTMF) and department project files.
* Performs periodic quality review of eTMF documents.
* Assists with taking meeting minutes and documenting/tracking study data management activities.
* Performs data archival activities.
* Performs inspection readiness activities and supports CDM team during internal and regulatory inspections
Data Collection Systems
* May support the set-up and testing of study data collection tools.
Additional Activities
* Assists with quality review of above activities performed by the CRO, as needed.
* Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
* Performs other duties as assigned.
Educational Qualifications
* Associate or Bachelor's Degree preferred
Experience
* Ideally 1 or more years relevant work experience, or equivalent combination of training and experience.
* Familiar with electronic data collection systems
* Preferred knowledge of data management best practices & technologies as applied to clinical trials.
* Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
Special Skills/Abilities
* Strong attention to detail, and organizational skills
* Good time management skills
* Quick learner and comfortable learning new technologies and systems
* Good knowledge of office software (Microsoft Office).
Behavioral Competencies
* Is comfortable with ambiguity.
* Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
Clinical Data Specialist
Posted 3 days ago
Job Viewed
Job Description
Role: Clinical Data specialist
Skill: CDM, Rave
Mode: Hybrid
Experience: 2-5 years in Clinical Data management
Job Location: Kochi/Kolkata/Bangalore
Educational Qualification: Any life science graduate
Job Overview:
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Essential Functions
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
- May serve in the role of back-up to a DOC or DTL.
- May conduct data review.
- May write and resolve data clarifications.
- May lead database audit team.
- May develop and test databases and edit specifications.
- May perform testing of programming.
- May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."
Qualifications
- Bachelor's Degree Clinical, biological , or related field Req
- Equivalent combination of education, training and experience in lieu of degree.
Clinical Data Specialist
Posted 3 days ago
Job Viewed
Job Description
Role: Clinical Data specialist
Skill: CDM, Rave
Mode: Hybrid
Experience: 2-5 years in Clinical Data management
Job Location: Kochi/Kolkata
Educational Qualification: Any life science graduate
Job Overview:
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Essential Functions
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
- May serve in the role of back-up to a DOC or DTL.
- May conduct data review.
- May write and resolve data clarifications.
- May lead database audit team.
- May develop and test databases and edit specifications.
- May perform testing of programming.
- May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."
Qualifications
- Bachelor's Degree Clinical, biological , or related field Req
- Equivalent combination of education, training and experience in lieu of degree.
Clinical Data Manager
Posted 4 days ago
Job Viewed
Job Description
Experience: 5+ yrs
Work Mode: Work from Office
Work Location: Bangalore
LOOKING FOR IMMEDIATE JOINERS ONLY
Job Description - Clinical Data Manager :
OVERVIEW
The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.
KEY TASKS & RESPONSIBILITIES
• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.
• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.
• Perform Query Management
• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.
• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
• Other duties as assigned.
CANDIDATE’S PROFILE:
Education & Experience
• 5+ years’ experience in Clinical Data Management preferred.
• Bachelor’s degree in a health-related field or equivalent experience preferred.
• CCDM Certification preferred.
Professional Skills
• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication
Technical Skills
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.
• Experience with RBQM methodology preferred.
• Exposure to CDISC guidelines and standards
Clinical Data Manager
Posted today
Job Viewed
Job Description
Role: Associate Manager - Clinical Data Management
Location: Chennai, Tamil Nadu
Experience: 10+ Years
Requirements:
- 10-12 years of experience in clinical trial/data management and data operations.
- Minimum 4-5 years of people management (preferred) experience with proven supervisory
- skills.
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
- Strong background in EDC systems management and clinical data operations.
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple
- therapeutic areas.
Technical Expertise
- CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
- Deep knowledge of EDC platforms and system integrations.
- Strong understanding of regulatory requirements (HIPPA, FDA, EMA, ICH-GCP).
- Experience with electronic systems validation and 21 CFR Part 11 compliance.
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Clinical Data Specialist
Posted today
Job Viewed
Job Description
Role: Clinical Data specialist
Skill: CDM, Rave
Mode: Hybrid
Experience: 2-5 years in Clinical Data management
Job Location: Kochi/Kolkata
Educational Qualification: Any life science graduate
Job Overview:
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Essential Functions
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
- May serve in the role of back-up to a DOC or DTL.
- May conduct data review.
- May write and resolve data clarifications.
- May lead database audit team.
- May develop and test databases and edit specifications.
- May perform testing of programming.
- May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."
Qualifications
- Bachelor's Degree Clinical, biological , or related field Req
- Equivalent combination of education, training and experience in lieu of degree.
Clinical Data Specialist
Posted today
Job Viewed
Job Description
Role: Clinical Data specialist
Skill: CDM, Rave
Mode: Hybrid
Experience: 2-5 years in Clinical Data management
Job Location: Kochi/Kolkata/Bangalore
Educational Qualification: Any life science graduate
Job Overview:
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Essential Functions
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
- May serve in the role of back-up to a DOC or DTL.
- May conduct data review.
- May write and resolve data clarifications.
- May lead database audit team.
- May develop and test databases and edit specifications.
- May perform testing of programming.
- May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."
Qualifications
- Bachelor's Degree Clinical, biological , or related field Req
- Equivalent combination of education, training and experience in lieu of degree.
Clinical Data Manager
Posted today
Job Viewed
Job Description
Experience: 5+ yrs
Work Mode: Work from Office
Work Location: Bangalore
LOOKING FOR IMMEDIATE JOINERS ONLY
Job Description - Clinical Data Manager :
OVERVIEW
The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.
KEY TASKS & RESPONSIBILITIES
• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
• Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies.
• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.
• Perform Query Management
• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities.
• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
• Other duties as assigned.
CANDIDATE’S PROFILE:
Education & Experience
• 5+ years’ experience in Clinical Data Management preferred.
• Bachelor’s degree in a health-related field or equivalent experience preferred.
• CCDM Certification preferred.
Professional Skills
• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication
Technical Skills
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.
• Experience with RBQM methodology preferred.
• Exposure to CDISC guidelines and standards