Clinical Data Specialist
3 weeks ago
About TheRole
Yourresponsibilities include but are not limitedto:
Contribute to electronic CaseReport Form (eCRF) development with a thorough understanding ofdata to be collected and in alignment with theprotocol.
Support the assessment of new datacollection requirements in assigned studies and provide clinicalinput into the development of new and updated clinical DataStandards (for CRFs as well as 3rd party data collectionmethodologies) for assigned trials/therapy areas asneeded.
Provide timely information for andsupport the setup and finalization of accurate and highquality DataTransfer Specification (DTS) documents.
Helpdefine a timely transfer schedule for rapid data availability andreview. Act as facilitator / problem solver between all partiesinvolved (e.g. clinical functions data operations vendors) tostreamline and accelerate DTS finalization andrevision.
Provide expert input into the DataQuality Plan (DQP) with a focus on clinical checks (e.g. usingstandard library checks and accounting for studyspecific needs) anddata risks.
Conduct regular Clinical DataReviews (CDR) in consultation with the Clinical Data Analyst andclinical team (e.g. routine review for DB lock Interim AnalysisSnapshots etc) and according to the DQP utilizing visual outputslistings and other outputs as appropriate.
LeadCDR meetings keep track and file CDR meetings outcomes and actions.Raise and resolve queries related to CDR in the clinical database.Highlight any significant risk trend data discrepancies processdeviations at Data Quality Team (DQT) meetings.
Identify track and resolve Protocol Deviations (PDs) as perNovartis processes. Detect potential PDs based on regular clinicaldata review evaluate nonimportant PDs ensure medical review asneeded file monthly PD listing detect trends and take actions asrequired.
Diversity Inclusion /EEO
We are committed to building an outstandinginclusive work environment and diverse teams representative of thepatients and communities weserve.
RoleRequirements
- 34 yearsrelevant experience Clinical Trial Design
- 34years relevant Data Review Reporting
- Diverseeducational backgrounds including scientists with various LifeSciences backgrounds and Health Care Professionals such asPharmacists Nurses Medical doctors orDentists.
- relevant experience in areas such asClinical Data Review
- relevant experience inClinical Data Management
- relevant experiencein Pharmacovigilance
- relevant experience inClinical Project Management.
Pleaseuse the below link for job application and quickerresponse.
RemoteWork :
No
-
Clinical Programmer
4 weeks ago
Hyderabad, India Worldcare Clinical Full time**Title**: Clinical Programmer **Department**: Engineering Support the organization’s mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, commitment to our community, and accountability and ownership. Job SummaryPrimary responsibilities are clinical programming and data...
-
Associate Clinical Data Manager
1 month ago
hyderabad, India Statistics & Data Corporation (SDC) Full timeAssociate Clinical Data Manager 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...
-
Clinical Data Specialist
4 weeks ago
Hyderabad, India Lifelancer Full timeAbout The RoleYour responsibilities include, but are not limited to:Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and...
-
Clinical Data Specialist
1 month ago
hyderabad, India Novartis Full timeYour responsibilities include, but are not limited to:•Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.•Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and updated...
-
Clinical Data Specialist
4 weeks ago
hyderabad, India Lifelancer Full timeAbout The Role Your responsibilities include, but are not limited to: Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol. Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new...
-
Clinical Research Coordinator
1 month ago
Hyderabad, India PULSE CLINICAL RESEARCH Full timeEligibility: - Graduate / Post Graduates in Life Sciences/ Pharmacy from a reputed institute - Prior knowledge of the conduct of Clinical Trials, - Phases of Clinical trials and - Thorough Knowledge of ICH-GCP and other regulatory guidelines. Roles and Responsibilities: - Prepare the Database of the Investigators at the place assigned to you. - Interact...
-
hyderabad, India Seven Consultancy Full timeJOB DETAILS 1) Evaluate health message scripts and content for clinical accuracy.2) Check documents (mentioned above) developed by copywriters for clinical and scientific, reporting errors by checking the developed material against annotated references, clinical guidelines, other published sources data3) Check for discrepancy within different...
-
Clinical Data Manager
19 hours ago
Hyderabad, India Signant Health Full timeClinical Data Manager - OperationsIndia, Hyderabad, Telangana, India Req #2697 Wednesday, April 24, 2024Role: Clinical Data ManagerLocations: Hyderabad/Bangalore/NoidaShift: 4pm - 1am ISTAre you ready for the Most Impactful Work of Your Life?Signant Health is a global evidence generation company. We’re helping our customers digitally enable their clinical...
-
Senior Clinical Data Manager
1 day ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Clinical Data Manager
1 month ago
Hyderabad, India EMentor Enterprises Private Limited Full timePosition: Clinical DataManagerRequirement: ImmediateJoinerLocation:HyderabadExperience: 3 to 10YearsKey Roles &Responsibilities:Provide leadership and vision tothe team.Manage and deliver largescalehighcomplexity studies across a range of sponsors and therapeuticareas.Manage sponsors at both the study andprogram levels.Ensure milestones meettimelines and...
-
Clinical Data Manager
1 day ago
Hyderabad, India Signant Health Full timeClinical Data Manager - Operations India, Hyderabad, Telangana, India Req #2697 Wednesday, April 24, 2024 Role: Clinical Data Manager Locations: Hyderabad/Bangalore/Noida Shift: 4pm - 1am IST Are you ready for the Most Impactful Work of Your Life? Signant Health is a global evidence generation company. We’re helping our customers...
-
Clinical Data Manager
2 days ago
hyderabad, India Signant Health Full timeClinical Data Manager - Operations India, Hyderabad, Telangana, India Req #2697 Wednesday, April 24, 2024 Role: Clinical Data Manager Locations: Hyderabad/Bangalore/Noida Shift: 4pm - 1am IST Are you ready for the Most Impactful Work of Your Life? Signant Health is a global evidence generation company. We’re helping...
-
Senior Clinical Data Analyst
1 day ago
Hyderabad, Telangana, India Parexel Full timeJob Purpose:The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership...
-
Senior Manager Clinical Data Management
1 day ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Clinical Data Analyst I
18 hours ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Key Accountabilities: Data Validation (cleaning): Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA), e.g. query management and manual/SAS listing reviews. Support/start to lead data processing activities from database setup to...
-
Senior Clinical Data Manager
19 hours ago
Hyderabad, India Signant Health Full timeSenior Clinical Data Manager - OperationsIndia, Hyderabad, Telangana, India Req #2695 Wednesday, April 24, 2024Role: Senior Clinical Data ManagerLocations: Hyderabad/Bangalore/NoidaShift: 4pm - 1am ISTAre you ready for the Most Impactful Work of Your Life?Signant Health is a global evidence generation company. We’re helping our customers digitally enable...
-
Clinical Coordinator
4 weeks ago
Hyderabad, India Mother to be Fertility Full timeThe primary responsibility of the Clinical Coordinator is to ensure smooth flow of all the clinical operations. - Responsible for smooth running of the unit and patient experience. - Ensures work is performed in accordance with internal SOPs and working practices, and other regulations. Coordinate with all doctors in the clinic - Effectively communicate...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Senior Clinical Data Manager
1 day ago
Hyderabad, India Signant Health Full timeSenior Clinical Data Manager - Operations India, Hyderabad, Telangana, India Req #2695 Wednesday, April 24, 2024 Role: Senior Clinical Data Manager Locations: Hyderabad/Bangalore/Noida Shift: 4pm - 1am IST Are you ready for the Most Impactful Work of Your Life? Signant Health is a global evidence generation company. We’re helping...
-
Senior Clinical Data Manager
2 days ago
hyderabad, India Signant Health Full timeSenior Clinical Data Manager - Operations India, Hyderabad, Telangana, India Req #2695 Wednesday, April 24, 2024 Role: Senior Clinical Data Manager Locations: Hyderabad/Bangalore/Noida Shift: 4pm - 1am IST Are you ready for the Most Impactful Work of Your Life? Signant Health is a global evidence generation company....