CT Disclosure Manager

Bristol Myers Squibb

3 - 6 years

9 - 13 Lacs

hyderabad

Posted:5 days ago| Platform:

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Skills Required

biostatistics innovation operational support resource regulatory career development scope management change management technology solutions los operations stakeholder management writing clinical trials internal communication communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

BRISTOL-MYERS SQUIBB INDIA PVT.LTD. is looking for CT Disclosure Manager to join our team

Manage and coordinate the redaction of clinical documents according to EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.
Perform quality control on redacted documents and provide vendor oversight for document redaction.
Manage and track redaction book-of-work and compile/ report on volume and performance metrics.
Work with IT to implement technology solutions related to clinical trial disclosure.
Provide operational support to CT Results Managers as needed.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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