CT Submission Specialist
Bristol-Myers Squibb
CT Submission Specialist
Job Description
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission Support the creation and coordination of the operational deliverables for FDA submissions Supports the GDO Submissions Document team with preparing and performing a quality check on Clinical submission deliverables. Supports the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations. Partners with the Clinical Trial Support Specialists (CTSS) for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents. Ensures documents are formatted appropriately and Submission Ready Compliant (SRC) Identifies issues and addresses responses to issues. Escalates issues regarding document risks to appropriate stakeholders and/or functional management, to expedite resolution. Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items. Other duties assigned to support Clinical Trials. Supporting People with Disabilities Minimum of a bachelor's degree in Life science, Business Administration, or equivalent experience. BS/BA Degree with approximately 3-4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 1-2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus. 1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field. Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma. Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred. Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies. Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template). Strong project management skills. Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals. Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure. Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts. Demonstrated ability to work independently and seek out support when needed. Strong understanding of protocol-related documents, and document management systems (e.g. CORE template). Exceptional written and oral communication skills.
About the Role/Company
- Part of Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM) / CT Transparency & Submission
- Supports People with Disabilities
Key Responsibilities
- Support the creation and coordination of operational deliverables for FDA submissions
- Assist the GDO Submissions Document team with preparing and performing quality checks on Clinical submission deliverables
- Support the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations
- Partner with Clinical Trial Support Specialists (CTSS) for the timing and creation of submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents
- Ensure documents are formatted appropriately and Submission Ready Compliant (SRC)
- Identify issues and address responses to issues
- Escalate issues regarding document risks to appropriate stakeholders and/or functional management to expedite resolution
- Apply critical thinking, develop mitigation and resolution strategies, and promptly respond to action items
- Perform other duties assigned to support Clinical Trials
Required Qualifications
- Bachelor's degree in Life Science, Business Administration, or equivalent experience
- -4 years of pharmaceutical or biotech experience in a clinical drug development setting
- -2 years in the pharmaceutical, biotech, or CRO environment
- -2 years of relevant experience in clinical trial documentation management or a clinically related field
- Demonstrated knowledge of ICH/GCP and regulatory guidelines/directives
- Understanding of the drug development process and Pharma
Preferred Qualifications
- Advanced degree
- Experience with Veeva Vault Clinical
- Experience with CTMS (Veeva Vault)
Skills Required
- Experience with industry Clinical Trial Master File Systems or equivalent
- Proficiency with MS Office suite, SharePoint, etc.
- Knowledge of portals, databases, and other Clinical Trial enabling technologies
- Thorough knowledge of document creation and document management systems and requirements (e.g., Core Template)
- Strong project management skills
- Strong organizational, time-management, analytical, and decision-making skills to efficiently evaluate, plan, and accomplish work goals
- Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure
- Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts
- Demonstrated ability to work independently and seek out support when needed
- Strong understanding of protocol-related documents and document management systems (e.g., CORE template)
- Exceptional written and oral communication skills
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
300,000 - 600,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience with industry Clinical Trial Master File Systems or equivalentintermediate
- Proficiency with MS Office suite, SharePoint, etc.intermediate
- Knowledge of portals, databases, and other Clinical Trial enabling technologiesintermediate
- Thorough knowledge of document creation and document management systems and requirements (e.g., Core Template)intermediate
- Strong project management skillsintermediate
- Strong organizational, time-management, analytical, and decision-making skills to efficiently evaluate, plan, and accomplish work goalsintermediate
- Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structureintermediate
- Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement effortsintermediate
- Demonstrated ability to work independently and seek out support when neededintermediate
- Strong understanding of protocol-related documents and document management systems (e.g., CORE template)intermediate
- Exceptional written and oral communication skillsintermediate
Required Qualifications
- Bachelor's degree in Life Science, Business Administration, or equivalent experience (experience)
- -4 years of pharmaceutical or biotech experience in a clinical drug development setting (experience)
- -2 years in the pharmaceutical, biotech, or CRO environment (experience)
- -2 years of relevant experience in clinical trial documentation management or a clinically related field (experience)
- Demonstrated knowledge of ICH/GCP and regulatory guidelines/directives (experience)
- Understanding of the drug development process and Pharma (experience)
Preferred Qualifications
- Advanced degree (experience)
- Experience with Veeva Vault Clinical (experience)
- Experience with CTMS (Veeva Vault) (experience)
Responsibilities
- Support the creation and coordination of operational deliverables for FDA submissions
- Assist the GDO Submissions Document team with preparing and performing quality checks on Clinical submission deliverables
- Support the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations
- Partner with Clinical Trial Support Specialists (CTSS) for the timing and creation of submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents
- Ensure documents are formatted appropriately and Submission Ready Compliant (SRC)
- Identify issues and address responses to issues
- Escalate issues regarding document risks to appropriate stakeholders and/or functional management to expedite resolution
- Apply critical thinking, develop mitigation and resolution strategies, and promptly respond to action items
- Perform other duties assigned to support Clinical Trials
Tags & Categories
CT Submission Specialist
Bristol-Myers Squibb
CT Submission Specialist
Job Description
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission Support the creation and coordination of the operational deliverables for FDA submissions Supports the GDO Submissions Document team with preparing and performing a quality check on Clinical submission deliverables. Supports the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations. Partners with the Clinical Trial Support Specialists (CTSS) for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents. Ensures documents are formatted appropriately and Submission Ready Compliant (SRC) Identifies issues and addresses responses to issues. Escalates issues regarding document risks to appropriate stakeholders and/or functional management, to expedite resolution. Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items. Other duties assigned to support Clinical Trials. Supporting People with Disabilities Minimum of a bachelor's degree in Life science, Business Administration, or equivalent experience. BS/BA Degree with approximately 3-4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 1-2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus. 1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field. Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma. Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred. Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies. Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template). Strong project management skills. Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals. Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure. Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts. Demonstrated ability to work independently and seek out support when needed. Strong understanding of protocol-related documents, and document management systems (e.g. CORE template). Exceptional written and oral communication skills.
About the Role/Company
- Part of Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM) / CT Transparency & Submission
- Supports People with Disabilities
Key Responsibilities
- Support the creation and coordination of operational deliverables for FDA submissions
- Assist the GDO Submissions Document team with preparing and performing quality checks on Clinical submission deliverables
- Support the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations
- Partner with Clinical Trial Support Specialists (CTSS) for the timing and creation of submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents
- Ensure documents are formatted appropriately and Submission Ready Compliant (SRC)
- Identify issues and address responses to issues
- Escalate issues regarding document risks to appropriate stakeholders and/or functional management to expedite resolution
- Apply critical thinking, develop mitigation and resolution strategies, and promptly respond to action items
- Perform other duties assigned to support Clinical Trials
Required Qualifications
- Bachelor's degree in Life Science, Business Administration, or equivalent experience
- -4 years of pharmaceutical or biotech experience in a clinical drug development setting
- -2 years in the pharmaceutical, biotech, or CRO environment
- -2 years of relevant experience in clinical trial documentation management or a clinically related field
- Demonstrated knowledge of ICH/GCP and regulatory guidelines/directives
- Understanding of the drug development process and Pharma
Preferred Qualifications
- Advanced degree
- Experience with Veeva Vault Clinical
- Experience with CTMS (Veeva Vault)
Skills Required
- Experience with industry Clinical Trial Master File Systems or equivalent
- Proficiency with MS Office suite, SharePoint, etc.
- Knowledge of portals, databases, and other Clinical Trial enabling technologies
- Thorough knowledge of document creation and document management systems and requirements (e.g., Core Template)
- Strong project management skills
- Strong organizational, time-management, analytical, and decision-making skills to efficiently evaluate, plan, and accomplish work goals
- Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure
- Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts
- Demonstrated ability to work independently and seek out support when needed
- Strong understanding of protocol-related documents and document management systems (e.g., CORE template)
- Exceptional written and oral communication skills
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
300,000 - 600,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience with industry Clinical Trial Master File Systems or equivalentintermediate
- Proficiency with MS Office suite, SharePoint, etc.intermediate
- Knowledge of portals, databases, and other Clinical Trial enabling technologiesintermediate
- Thorough knowledge of document creation and document management systems and requirements (e.g., Core Template)intermediate
- Strong project management skillsintermediate
- Strong organizational, time-management, analytical, and decision-making skills to efficiently evaluate, plan, and accomplish work goalsintermediate
- Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structureintermediate
- Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement effortsintermediate
- Demonstrated ability to work independently and seek out support when neededintermediate
- Strong understanding of protocol-related documents and document management systems (e.g., CORE template)intermediate
- Exceptional written and oral communication skillsintermediate
Required Qualifications
- Bachelor's degree in Life Science, Business Administration, or equivalent experience (experience)
- -4 years of pharmaceutical or biotech experience in a clinical drug development setting (experience)
- -2 years in the pharmaceutical, biotech, or CRO environment (experience)
- -2 years of relevant experience in clinical trial documentation management or a clinically related field (experience)
- Demonstrated knowledge of ICH/GCP and regulatory guidelines/directives (experience)
- Understanding of the drug development process and Pharma (experience)
Preferred Qualifications
- Advanced degree (experience)
- Experience with Veeva Vault Clinical (experience)
- Experience with CTMS (Veeva Vault) (experience)
Responsibilities
- Support the creation and coordination of operational deliverables for FDA submissions
- Assist the GDO Submissions Document team with preparing and performing quality checks on Clinical submission deliverables
- Support the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations
- Partner with Clinical Trial Support Specialists (CTSS) for the timing and creation of submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents
- Ensure documents are formatted appropriately and Submission Ready Compliant (SRC)
- Identify issues and address responses to issues
- Escalate issues regarding document risks to appropriate stakeholders and/or functional management to expedite resolution
- Apply critical thinking, develop mitigation and resolution strategies, and promptly respond to action items
- Perform other duties assigned to support Clinical Trials
Tags & Categories