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| Job Location | Pune |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Allied Health Services |
| EmploymentType | Full-time |
Sr Clinical Data Manager Job details Job Details Sr Clinical Data Manager Description : To co- ordinate and study manage allocated projects (resource, budget and timelines). Provide training on data management procedures and systems as required. To liaise with customers and be responsible for the sponsor- customer interface, at the study management level as required. To represent data management on study/ project team meetings (external and internal). Track study progress and issue periodic status reports. To understand and monitor the scope of work and raise any necessary out of scopes. To negotiate and/ or assist with defining the study data management timelines. To prepare and support all data management set up activities. To design and develop clinical case report forms. Set up or define the set- up of the clinical data management system (database). To provide study progress and metrics reporting to clients. To code adverse events, medical history and medications either manually or using the auto- coder (CRO or customer). To be aware of and to work to the standards appropriate to the study (CRO or client). To advise on possible improvements to procedures and standards. To perform other reasonable tasks as requested by management. To supervise other team members and to perform QC on other team members work. Line manage staff as required. To perform the QC procedures on project/ study related documentation. To fulfil job responsibilities in accordance with Good Clinical Practice (GCP), Company Standard Operating Procedures (SOPs), Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations. ,
Keyskills :
data managementclinical trialscustomer relationsdatabase administrationclinical data managementstandard operating proceduresmetrics reporting