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Bristol-Myers Squibb

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3.9

based on 134 Reviews

74 Bristol-Myers Squibb Jobs

Quality and Training Clinical Trial Disclosure Manager

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

3.9

based on 134 Reviews

4-9 years

Hyderabad / Secunderabad

1 vacancy

Quality and Training Clinical Trial Disclosure Manager

Bristol-Myers Squibb

posted 1mon ago

Job Role Insights

Flexible timing

Key skills for the job

Medical Writing QC Operations Recruitment Data Privacy Training

+ 3 more

Job Description

The Quality and Training Clinical Trial Disclosure Manager will provide operational Quality and Training support for redaction of clinical trial documents .

Ensure quality oversight of redacted documents and adherence to redaction processes.
Oversee the QC process and deliverables for all regulations.
Perform quality control of redacted documents.
Develop QC training materials and drive QC process improvement.
Compile QC and compliance metrics.
Coach and support CTD team members on matters related to CT document redaction and QC process.
Train and educate stakeholders on redaction processes.
Train new staff and develop job aids, work instructions, and user guides, as needed.
Manage and coordinate projects related to the redaction of clinical documents in accordance with EU Clinical Trial Regulation (EUCTR), EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), and other global regulations.
Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.
Provide vendor oversight to support redaction of documents.
Stay current with the Clinical Trial Transparency regulatory landscape and provides risk assessments for policies changes and updates.
Communicate with internal and external stakeholders to improve on processes and manage unmet need.
Drive the development and implementation of technology solutions related to clinical trial disclosure.