1,161 Clinical jobs in India
Clinical Study Builder
Posted today
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Job Description
**Education**
- ***B.Sc. or M.Sc, or in a related field of study;
*
**Experience**
- Minimum of 2 years of Veeva CDMS study build experience;
- Knowledge and skills
- Certified Veeva Study Builders preferred.
- Medidata Rave build experience preferred.
- Detailed knowledge and experience in case report form design, programming databases;
- Must be able to lead multiple study builds or post-release changes at the same time;
- Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;
- Highly organized and detail-oriented with effective project planning and time management skills.
- Strong verbal and written communication skills in English;
- Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.
Pay: ₹12,477.86 - ₹49,854.83 per month
Work Location: Remote
TL-Clinical Data Management
Posted 1 day ago
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Job Description
1. **6 yrs of minimum Clinical Data Management experience**
2. **Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases.**
3. **Rave (Medidata) or Veeva EDC hands on experience is must.**
**Must Have:**
**Setup experience should have knowledge of**
DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory).
**Conduct Experience**
Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc **.**
**Study Lock**
Freezing/Locking, should have good experience of Study lock
**Client facing role and Mentoring are added advantage.**
1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities.
2 Participate in innovation and process improvement initiatives.
3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs.
4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.
5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
6 Study Setup hands on experience.
7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool ,
8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
SME-Clinical Data Management
Posted 1 day ago
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Job Description
1. **4 - 6 yrs of minimum Clinical Data Management experience**
2. **Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases.**
3. **Rave (Medidata) or Veeva EDC hands on experience is must.**
**Must Have:**
**Setup experience should have knowledge of**
DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory).
**Conduct Experience**
Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc **.**
**Study Lock**
Freezing/Locking, should have good experience of Study lock
**Client facing role and Mentoring are added advantage.**
1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities.
2 Participate in innovation and process improvement initiatives.
3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs.
4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.
5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
6 Study Setup hands on experience.
7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool ,
8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
SPE-Clinical Data Management
Posted 1 day ago
Job Viewed
Job Description
1. **2 to 3 yrs of minimum Clinical Data Management experience**
2. **Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases.**
3. **Rave (Medidata) or Veeva EDC hands on experience is must.**
**Must Have:**
**Setup experience should have knowledge of**
DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory).
**Conduct Experience**
Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc **.**
**Study Lock**
Freezing/Locking, should have good experience of Study lock
**Client facing role and Mentoring are added advantage.**
1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities.
2 Participate in innovation and process improvement initiatives.
3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs.
4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.
5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
6 Study Setup hands on experience.
7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool ,
8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication)
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Manager 2-Clinical Data Management
Posted 1 day ago
Job Viewed
Job Description
The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations
**Area Of Responsibility**
1. Effective management of all data management aspects of assigned project(s) from setup to lock.
2. Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project.
3. Report on quality and performance metrics, including timelines, to project leads and other stakeholders
4. Participate in in-house and external training courses, where required.
5. Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc.
6. Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.
7. Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.
8. Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
9. Maintain Data Management study documentation in an audit-ready status,
10. Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.
11. May present at investigator meetings and PM/CRA training sessions.
12. Identifies and recommends process improvements to management team, as identified.
Geographic Scope/ Market
Global
Budget (if applicable)
Work Conditions:
Full time
Physical Requirements:
Presence at work
Travel Estimate
Infrequent
**Education and Job Qualification**
Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline
**Experience**
Minimum 6 years of clinical data management experience including working knowledge using clinical data capture tool. Experience of leading global clinical studies is preferred
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Sr. Executive-Clinical Data Management
Posted 1 day ago
Job Viewed
Job Description
The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations
**Area Of Responsibility**
1. Effective management of all data management aspects of assigned project(s) from setup to lock.
2. Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project.
3. Report on quality and performance metrics, including timelines, to project leads and other stakeholders
4. Participate in in-house and external training courses, where required.
5. Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc.
6. Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.
7. Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.
8. Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
9. Maintain Data Management study documentation in an audit-ready status,
10. Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.
11. May present at investigator meetings and PM/CRA training sessions.
12. Identifies and recommends process improvements to management team, as identified.
Geographic Scope/ Market
Global
Budget (if applicable)
Work Conditions:
Full time
Physical Requirements:
Presence at work
Travel Estimate
Infrequent
**Education and Job Qualification**
Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline
**Experience**
Executive-Minimum 3 years of clinical data management experience including working knowledge using clinical data capture tool
Sr. Executive- Minimum 5 years of clinical data management experience including working knowledge using clinical data capture tool. Experience of leading global clinical studies is preferred
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Manager 2-Clinical Data Management
Posted today
Job Viewed
Job Description
Job Summary
The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations
Area Of Responsibility
Geographic Scope/ Market
Global
Budget (if applicable)
Work Conditions:
Full time
Physical Requirements:
Presence at work
Travel Estimate
Infrequent
Education and Job Qualification
Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline
Experience
Minimum 6 years of clinical data management experience including working knowledge using clinical data capture tool. Experience of leading global clinical studies is preferred
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Sr. Executive-Clinical Data Management
Posted today
Job Viewed
Job Description
Job Summary
The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations
Area Of Responsibility
Geographic Scope/ Market
Global
Budget (if applicable)
Work Conditions:
Full time
Physical Requirements:
Presence at work
Travel Estimate
Infrequent
Education and Job Qualification
Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline
Experience
Executive-Minimum 3 years of clinical data management experience including working knowledge using clinical data capture tool
Sr. Executive-Minimum 5 years of clinical data management experience including working knowledge using clinical data capture tool. Experience of leading global clinical studies is preferred
Clinical Data Management - DA/SME
Posted 428 days ago
Job Viewed
Job Description
· Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks
· Triage of Safety cases
· Oversight of data discrepancy management
· Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF
· Responsible for compiling HoS content
· Conduct the protocol amendment impact assessment and complete appropriate documentation
· Manage migration and audit trail reports
· Create slides for study-specific EDC investigator training
· Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.
· Provide study specific training to data manager (DM)
· Contribute to the Data Management Plan (DMP)
· Request DTS creation and ensure DTS finalized and complete for any LSH loads
· Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)
· Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)
· Manage global and study-specific data entry conventions
· Facilitate versioning, including Unlock/audit trail review & Archival process
· Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design
· Timely communication with key stakeholders on issues and risks, including
o Brings CDR, DWA, and SD together to discuss post-production changes when identified
· Provide critical information to PL who will communicate with study team
· Log any action issues into DS Hub and resolve outstanding issues assigned to DA
· Mange assigned activities to meet milestone dates
· Ask questions to get information needed to meet end goals
· Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)
What you need
· A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree
· Minimum 2 years to 6 years of experience in clinical data management
· Proactively communicate ownership of studies
· Critical thinking to identify root causes and best solutions for data discrepancy management
· Confidence to have tough conversations and make challenging decisions
· Enables an environment of open and honest communication and critical thinking within DSS study team
· Influence internal team to meet timelines by holding stakeholders accountable
· Ability to work with different personalities to get the work done
· Willingness to seek out information to accomplish goal
· Proactive communication
Non-Clinical Study Support Associate
Posted today
Job Viewed
Job Description
Job Title: Study Monitor Support Specialist
Introduction to role:
Are you ready to dive into the world of non-clinical study monitoring? As a Study Monitor Support Specialist, you'll play a pivotal role in supporting the Study Monitor group within Regulatory Toxicology and Safety Pharmacology. Your contributions will be vital in ensuring the smooth execution of studies that pave the way for groundbreaking medical advancements.
Accountabilities:
-
Support NonClinical Toxicology Study Monitors with key study activities
Support of external study monitors by supporting key support activities
Maintain and update supporting documents
Support the identification and implementation of effective toxicology study processes within the study monitor group that improves efficiency and simplifies ways of working. Provide continued evaluation of the end-to-end process for CRO study management to identify weaknesses and gaps with a focus on improving and simplifying wherever possible.
Support financial aspects of study conduct (approval and review of Amended Statements OfWork / Invoices/ Purchase orders)
Maintain tracker for ongoing study costs
Support ad hoc request for metrics and information gathering activities
QC check of submission documents
Essential Skills/Experience:
Fluent in English (spoken and written)
Strong candidates will have some experience of working in a GLP Toxicology lab and understand the practices, principles and concepts associated with planning and delivering a fit for purpose non-clinical toxicology study
Ideally BSc in Pharmacology / Toxicology.
Experience of delivery to multiple concurrent projects.
Strong stakeholder management skills with excellent communication skills
Experience in improvement projects with a drive to ensure ways of working are efficient.
A dedicated team player with excellent communication and influencing skills with experience working in multidisciplinary matrix teamsacross a broad spectrum of geographical locations.
Results orientated with high scientific standards to support project execution.
Proficient in the use of Microsoft Office products
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are driven by curiosity and courage, constantly exploring new scientific frontiers to tackle some of the world's most complex diseases. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to achieve breakthroughs that impact billions of lives globally. Here, you will find an inclusive environment where collaboration thrives, empowering you to make bold decisions and celebrate successes along the way. With opportunities for lifelong learning and career growth, AstraZeneca is where you can truly make an impact.
Ready to take on this exciting challenge? Apply now and be part of our journey to redefine what's possible in healthcare!
Date Posted
16-Jul-2025Closing Date
22-Jul-2025