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Bristol Myers Squibb
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Senior Clinical Data Manager

Senior Clinical Data Manager

Bristol Myers Squibb

4 - 9 years

6 - 11 Lacs

hyderabad

Posted:6 days ago| Platform:

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Skills Required

data management hp data protector edc pharmacy clinical trials life sciences data quality data privacy clinical data recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities will include, but are not limited to:

Data Review :

Understand and review Protocol along with relevant study specific data review documents.
Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan
Review clinical data listings and prioritize critical data review.
Manage and facilitate resolution of data discrepancies.
Perform data cleaning as per the defined Clean Patient Group.
Freezing & Locking of CRFs/Fields.
Coordinate with Data Management Lead for study deliverables.

External Data:

Track data load and address discrepancies.
Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE
Coordinate with external data vendor for resolution of data discrepancies as applicable.

Documentation:

Filing of appropriate documents in eTMF as per eTMF master plan.

Training and Mentorship:

Provide Training and mentoring to junior CDM staff.

Requirements:

Bachelor s Degree required. Life sciences, Pharmacy or relevant fields preferred.

4 years of experience in Clinical Data Review tasks

Able to work on clinical data review tasks
Able to work collaboratively on multi-disciplinary project teams.
Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills.
Strong oral and written communication skills.

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