Clinical Data manager Hyderabad Bangalore Kolkata Mumbai Pune
Clinical Data manager Hyderabad Bangalore Kolkata Mumbai Pune
Posted on :
22-02-2025
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1 Vacancy
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Job Description
- Overseeing the management of data discrepancies
- Acting as the custodian of study documentation ensuring completeness and accuracy and conducting periodic reviews of eTMF/TMF
- Compiling content for the History of Science (HoS)
- Performing impact assessments for protocol amendments and completing necessary documentation
- Managing migration and audit trail reports
- Developing slides for studyspecific EDC investigator training
- Providing studyspecific training to data managers (DM)
- Contributing to the Data Management Plan (DMP)
- Requesting DTS creation and ensuring completion for any LSH loads
- Executing data review per IDRP including SAE reconciliation PK reconciliation shortterm/longterm reconciliation
- Managing tables in EDC for studyspecific inclusion/exclusion data (SDTM related to protocol)
- Managing global and studyspecific data entry conventions
- Facilitating versioning including unlock/audit trail review and archival processes
- Utilizing knowledge of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design
- Communicating timely with key stakeholders on issues and risks including coordinating discussions with CDR DWA and SD for postproduction changes
- Providing critical information to PL for communication with the study team
- Logging action issues into DS Hub and resolving outstanding issues assigned to DA
- Managing assigned activities to meet milestone dates
- Asking questions to gather information needed to achieve end goals
- Managing programmingonly changes and coordinating with DWA for LSH and SD
Requirements
Requirements:
- Bachelors degree in a relevant field
- Strong understanding of clinical data management processes and regulations
- Proficiency in data management systems and tools
- Excellent communication and coordination skills
- Ability to work effectively in a team and independently
- Attention to detail and strong organizational skills
- Knowledge of clinical trial protocols and procedures
- Familiarity with relevant industry standards and best practices
Mortgage
Education
Any
Employment Type
Full Time
Key Skills
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