Senior manager, Clinical Scientist

Bristol Myers Squibb

6 - 11 years

13 - 19 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

basic data management gcp project management clinical trials data collection life sciences microsoft medical writing clinical data

Work Mode

Work from Office

Job Type

Full Time

Job Description

Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
May serve as Clinical Trial Lead for one or more trials
May lead or support trial level activities for one or more trials with the necessary supervision
May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members

Position Responsibilities

Collaborate and liaise with external partners (e. g. , KOLs)
Seek out and enact best practices with instruction
Provide regular and timely updates to manager/management as requested
Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
Conduct literature review
Submit clinical documents to TMF
Develop site and CRA training materials and present these at SIVs and Investigator meetings
Review clinical narratives
Monitor clinical data for specific trends
Develop Data Review Plan in collaboration with Data Management
Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e. g. , IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission. )

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