Clinical Data Specialist
1 week ago
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 and updated clinical Data Standards (for CRFs as well as 3rd party data collection methodologies) for assigned trials/therapy areas as needed.
- Provide timely information for, and support the setup and finalization of, accurate and high-quality Data Transfer Specification (DTS) documents.
- Help define a timely transfer schedule for rapid data availability and review. Act as facilitator / problem solver between all parties involved (e.g., clinical functions, data operations, vendors) to streamline and accelerate DTS finalization and revision.
- Provide expert input into the Data Quality Plan (DQP) with a focus on clinical checks (e.g., using standard library checks and accounting for study-specific needs) and data risks.
- Conduct regular Clinical Data Reviews (CDR) in consultation with the Clinical Data Analyst and clinical team (e.g. routine review, for DB lock, Interim Analysis, Snapshots etc) and according to the DQP, utilizing visual outputs, listings, and other outputs as appropriate.
- Lead CDR 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, process deviations at Data Quality Team (DQT) meetings.
- Identify, track and resolve Protocol Deviations (PDs) as per Novartis processes. Detect potential PDs based on regular clinical data review, evaluate non-important PDs, ensure medical review as needed, file monthly PD listing, detect trends and take actions as required.
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Clinical Data Specialist
1 week ago
Hyderabad, Telangana, 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...
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Clinical Application Specialist
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Clinical Application Specialist
1 week ago
Hyderabad, Telangana, India United Imaging Healthcare Full timeClinical Application Specialist (MR/CT)Location: Hyderabad, India | Classification: Full-TimeWho we are?Shanghai United Imaging Healthcare Co., Ltd. is dedicated to providing, developing and producing high-performance advanced medical imaging, radiotherapy equipment, life science instruments and offers intelligent digital solutions to customers worldwide....
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Senior Clinical Data Manager
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Senior Clinical Data Manager
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Clinical Data Analyst I
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Senior Clinical Data Analyst
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Senior Manager Clinical Data Management
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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...
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Senior Manager Clinical Data Management
1 month 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...
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Senior Clinical Data Manager
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeWorking with Us Challenging. 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...
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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...
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Associate Manager, Clinical Data Management
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Associate Manager, Clinical Data Management
1 week ago
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