CT Disclosure Manager
Bristol-Myers Squibb
CT Disclosure Manager
Job Description
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission Manage and Coordinate redaction of clinical documents in accordance with 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 of redacted documents Provide vendor oversight to support document redaction, as appropriate Manage and track redaction book-of-work; compile and report on volume and performance metrics Work with IT, as needed, to implement technology solutions related to clinical trial disclosure Provide operational support to CT Results Managers, as required Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements Communicate with internal and external stakeholders to improve on processes and manage unmet need Train new staff and develop job aids, work instructions, and user guides, as needed Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations BA/BS or MA/MS in scientific or medical field 3-4 years of transparency experience and 6-8 years relevant work experience in a scientific or medical field with BA/BS Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies Familiarity and comfortability working with and discussing scientific data. Demonstrated ability to work independently and seek out support when needed. Strong organizational skills with the ability to multitask and prioritize.
About the Role/Company
- Part of Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission
Key Responsibilities
- Manage and coordinate redaction of clinical documents in accordance with 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 of redacted documents
- Provide vendor oversight to support document redaction, as appropriate
- Manage and track redaction book-of-work; compile and report on volume and performance metrics
- Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
- Provide operational support to CT Results Managers, as required
- Assist in monitoring the global regulatory environment and maintain working knowledge of disclosure requirements
- Communicate with internal and external stakeholders to improve on processes and manage unmet need
- Train new staff and develop job aids, work instructions, and user guides, as needed
- Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations
Required Qualifications
- BA/BS or MA/MS in scientific or medical field
- -4 years of transparency experience
- -8 years relevant work experience in a scientific or medical field with BA/BS
- Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies
Preferred Qualifications
- Familiarity and comfortability working with and discussing scientific data
Skills Required
- Demonstrated ability to work independently and seek out support when needed
- Strong organizational skills with the ability to multitask and prioritize
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
1,200,000 - 2,400,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated ability to work independently and seek out support when neededintermediate
- Strong organizational skills with the ability to multitask and prioritizeintermediate
Required Qualifications
- BA/BS or MA/MS in scientific or medical field (experience)
- -4 years of transparency experience (experience)
- -8 years relevant work experience in a scientific or medical field with BA/BS (experience)
- Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (experience)
Preferred Qualifications
- Familiarity and comfortability working with and discussing scientific data (experience)
Responsibilities
- Manage and coordinate redaction of clinical documents in accordance with 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 of redacted documents
- Provide vendor oversight to support document redaction, as appropriate
- Manage and track redaction book-of-work; compile and report on volume and performance metrics
- Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
- Provide operational support to CT Results Managers, as required
- Assist in monitoring the global regulatory environment and maintain working knowledge of disclosure requirements
- Communicate with internal and external stakeholders to improve on processes and manage unmet need
- Train new staff and develop job aids, work instructions, and user guides, as needed
- Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations
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Answer 10 quick questions to check your fit for CT Disclosure Manager @ Bristol-Myers Squibb.
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CT Disclosure Manager
Bristol-Myers Squibb
CT Disclosure Manager
Job Description
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission Manage and Coordinate redaction of clinical documents in accordance with 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 of redacted documents Provide vendor oversight to support document redaction, as appropriate Manage and track redaction book-of-work; compile and report on volume and performance metrics Work with IT, as needed, to implement technology solutions related to clinical trial disclosure Provide operational support to CT Results Managers, as required Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements Communicate with internal and external stakeholders to improve on processes and manage unmet need Train new staff and develop job aids, work instructions, and user guides, as needed Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations BA/BS or MA/MS in scientific or medical field 3-4 years of transparency experience and 6-8 years relevant work experience in a scientific or medical field with BA/BS Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies Familiarity and comfortability working with and discussing scientific data. Demonstrated ability to work independently and seek out support when needed. Strong organizational skills with the ability to multitask and prioritize.
About the Role/Company
- Part of Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission
Key Responsibilities
- Manage and coordinate redaction of clinical documents in accordance with 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 of redacted documents
- Provide vendor oversight to support document redaction, as appropriate
- Manage and track redaction book-of-work; compile and report on volume and performance metrics
- Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
- Provide operational support to CT Results Managers, as required
- Assist in monitoring the global regulatory environment and maintain working knowledge of disclosure requirements
- Communicate with internal and external stakeholders to improve on processes and manage unmet need
- Train new staff and develop job aids, work instructions, and user guides, as needed
- Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations
Required Qualifications
- BA/BS or MA/MS in scientific or medical field
- -4 years of transparency experience
- -8 years relevant work experience in a scientific or medical field with BA/BS
- Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies
Preferred Qualifications
- Familiarity and comfortability working with and discussing scientific data
Skills Required
- Demonstrated ability to work independently and seek out support when needed
- Strong organizational skills with the ability to multitask and prioritize
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
1,200,000 - 2,400,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated ability to work independently and seek out support when neededintermediate
- Strong organizational skills with the ability to multitask and prioritizeintermediate
Required Qualifications
- BA/BS or MA/MS in scientific or medical field (experience)
- -4 years of transparency experience (experience)
- -8 years relevant work experience in a scientific or medical field with BA/BS (experience)
- Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (experience)
Preferred Qualifications
- Familiarity and comfortability working with and discussing scientific data (experience)
Responsibilities
- Manage and coordinate redaction of clinical documents in accordance with 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 of redacted documents
- Provide vendor oversight to support document redaction, as appropriate
- Manage and track redaction book-of-work; compile and report on volume and performance metrics
- Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
- Provide operational support to CT Results Managers, as required
- Assist in monitoring the global regulatory environment and maintain working knowledge of disclosure requirements
- Communicate with internal and external stakeholders to improve on processes and manage unmet need
- Train new staff and develop job aids, work instructions, and user guides, as needed
- Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations
Tags & Categories
Answer 10 quick questions to check your fit for CT Disclosure Manager @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs