130 Clinical Management jobs in India
TL-Clinical Data Management
Posted 1 day ago
Job Viewed
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
Job Viewed
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
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
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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
Master Healthcare Administration(Bds/bhms,bams)
Posted today
Job Viewed
Job Description
- **Operations (International Marketing).**
Pay: ₹25,000.00 - ₹40,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Rotational shift
Work Location: In person
Senior Clinical Data Management (SAS) Programmer
Posted today
Job Viewed
Job Description
Senior Clinical Data Management Programmer
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Summary
Leads in the evaluation, implementation and validation of package systems to support Clinical Database review requests of all Clinical Database applications. Creates, maintains and oversees process for providing end user support for all Data review and ad hoc listings. Works very closely with Clinical Data Managers to develop study specifications listings and gain acceptance through user testing. Develops data quality listings to comply with related specifications and regulatory requirements. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance, and company SOPs. Communicates programming and related document review statuses to management and the project teams.
Primary Responsibilities
• Lead the development, validation, and maintenance of clinical reporting of clinical trials using a variety of validated software applications
• Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management documentation.
• Develop a variety of SAS/Data review/Visualization reports by integrating various sources of Data for efficient Clinical Data review and decision making
• Implement and test data quality checks in accordance with the study database specification listings.
• Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data)
• Serve as SME and facilitate integration of EDC systems to other clinical platforms such as CTMS, Reporting, and IRT as needed
• Assist in managing and providing listings to all medical coding dictionaries, including but not limited to MedDRA and WHODrug
• Oversee the management of Clinical report development, other GxP system user accounts and other help desk activities within Clinical reporting areas
• Develop EDC report listings, work with EDC vendors to resolve, and escalate issues appropriately to Senior Management.
• Work very closely with other functions to support ad hoc report development using tools such as Python, R Programming, Power BI, etc.
• Quickly learn new and/or advancements in software to become the SME for any technical question
• Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary
• Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance)
• Keep management team abreast of issues, progress, and risks related to trial operations
• Support bid defenses from a technical SME perspective
• Providing proactive ideas, support developing Insightful reports for supporting Data review process,
• Participate in other clinical programming and data management activities, as required
• Participate in internal and external team meetings, as required
• Mentor junior level clinical programmers
• Adhere to all aspects of the Statistics & Data Corporation’s quality system
• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance with business and regulatory requirements.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
• Excellent understanding of relational database structures
• Fast, accurate programming skills using assorted application software
• SAS, R Programming, Python, PL/SQL, SQL, and XML programming skills
• Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships
• Demonstrated ability to provide both “user-friendly” and technical documentation
• Good time management and organization skills, including the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work
• Ability to provide expertise to guide department in continued efficiency and growth
• Knowledge of FDA regulations and guidance (e.g., 21 CFR Part 11, ICH/GCP)
• Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment
• Good knowledge of industry standard EDC tools (Medidata Rave, iMedNet, Viedoc, Veeva, etc.)
• Knowledge of Reporting application development (e.g., JReview, Business Objects, Python, PowerBI) is required
Education or Equivalent Experience
• Bachelor’s degree in computer science or other quantitative or scientific discipline with 6+ years’ experience in database programming and demonstrated working knowledge of scientific principles.
• At least 6 years’ experience assuming lead report programming responsibilities on projects, with a minimum of 4 years in a clinical environment
• Experience with FDA regulations and guidance is required.
Benefits
Why SDC
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.
• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• e are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• W strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We re constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• W th a proven track record, SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team!
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