Senior Support Manager, Interactive Response Technology (Clinical Supply Chain)
Bristol-Myers Squibb
Senior Support Manager, Interactive Response Technology (Clinical Supply Chain)
Job Description
Supports UAT Services organization as required. Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles. Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed. Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team. Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency. Support key department and enterprise level initiatives as part of the IRT representative. Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high -risked areas and new functionality documented in the user requirements. Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes. Ensure effective system access and functionality across all countries and all user locations. Support unblinding activities as needed. Ensure on time development of IRT data transfers with vendors and/or third-party vendors. Ensure eTMF compliance at the study level in accordance with group and BMS guidance. Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms. Supporting People with Disabilities Minimum bachelor's degree Minimum of 3 to 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint. Clinical Research experience Working knowledge of IRT Working knowledge of Clinical Trial Management Systems Working knowledge of clinical supplies Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio. Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards. Exposure to working in a GMP / GCP environment and with regulatory audit teams. Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required Comfortable working with a global team, partners and customers in a change agile environment MS Project, MS Visio, or any other requirements visualization and analysis tools)
About the Role/Company
- Supports UAT Services organization as required
- Part of the IRT Team and involved in key department and enterprise level initiatives
Key Responsibilities
- Lead successful maintenance support and projects to ensure on-time delivery of Interactive Response Technology (IRT) changes, data, and support integrations with other clinical systems
- Ensure IRTs are fit-for-purpose as defined by protocol and study operational parameters with adherence to BMS standards and quality principles
- Work independently and assume support role responsibilities on assigned projects
- Collaborate with the IRT Team to ensure BMS standards and address requests by study teams that are not within these standards or best practice
- Generate and oversee patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements
- Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team
- Support IRT improvement initiatives and manage improvement projects that impact daily operations to improve efficiency
- Support key department and enterprise level initiatives as part of the IRT representative
- Ensure on-time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures
- Write or review User Acceptance Test Plan and causes to ensure thorough testing of high-risked areas and new functionality documented in the user requirements
- Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance with BMS SOPs and processes
- Ensure effective system access and functionality across all countries and all user locations
- Support unblinding activities as needed
- Ensure on-time development of IRT data transfers with vendors and/or third-party vendors
- Ensure eTMF compliance at the study level in accordance with group and BMS guidance
- Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms
Required Qualifications
- Minimum bachelor's degree
- to 5 years of work experience in health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.)
- Demonstrated analytical skills
- Working knowledge of Microsoft Office including SharePoint
- Working knowledge of IRT
- Working knowledge of Clinical Trial Management Systems
- Working knowledge of clinical supplies
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Excellent English language written and verbal communication skills
Preferred Qualifications
- Clinical Research experience
- Ability to think outside of the box
Skills Required
- Excellent communication skills
- Analytical skills
- Ability to deliver optimal IRT solutions across a diverse and dynamic portfolio
- Understanding of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
- Interpersonal, collaboration, and business partnership capabilities
- Comfortable working with a global team, partners, and customers in a change agile environment
- Proficiency in MS Project, MS Visio, or other requirements visualization and analysis tools
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
60,000 - 100,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Excellent communication skillsintermediate
- Analytical skillsintermediate
- Ability to deliver optimal IRT solutions across a diverse and dynamic portfoliointermediate
- Understanding of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standardsintermediate
- Interpersonal, collaboration, and business partnership capabilitiesintermediate
- Comfortable working with a global team, partners, and customers in a change agile environmentintermediate
- Proficiency in MS Project, MS Visio, or other requirements visualization and analysis toolsintermediate
Required Qualifications
- Minimum bachelor's degree (experience)
- to 5 years of work experience in health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) (experience)
- Demonstrated analytical skills (experience)
- Working knowledge of Microsoft Office including SharePoint (experience)
- Working knowledge of IRT (experience)
- Working knowledge of Clinical Trial Management Systems (experience)
- Working knowledge of clinical supplies (experience)
- Exposure to working in a GMP / GCP environment and with regulatory audit teams (experience)
- Excellent English language written and verbal communication skills (experience)
Preferred Qualifications
- Clinical Research experience (experience)
- Ability to think outside of the box (experience)
Responsibilities
- Lead successful maintenance support and projects to ensure on-time delivery of Interactive Response Technology (IRT) changes, data, and support integrations with other clinical systems
- Ensure IRTs are fit-for-purpose as defined by protocol and study operational parameters with adherence to BMS standards and quality principles
- Work independently and assume support role responsibilities on assigned projects
- Collaborate with the IRT Team to ensure BMS standards and address requests by study teams that are not within these standards or best practice
- Generate and oversee patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements
- Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team
- Support IRT improvement initiatives and manage improvement projects that impact daily operations to improve efficiency
- Support key department and enterprise level initiatives as part of the IRT representative
- Ensure on-time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures
- Write or review User Acceptance Test Plan and causes to ensure thorough testing of high-risked areas and new functionality documented in the user requirements
- Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance with BMS SOPs and processes
- Ensure effective system access and functionality across all countries and all user locations
- Support unblinding activities as needed
- Ensure on-time development of IRT data transfers with vendors and/or third-party vendors
- Ensure eTMF compliance at the study level in accordance with group and BMS guidance
- Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms
Tags & Categories
Senior Support Manager, Interactive Response Technology (Clinical Supply Chain)
Bristol-Myers Squibb
Senior Support Manager, Interactive Response Technology (Clinical Supply Chain)
Job Description
Supports UAT Services organization as required. Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles. Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed. Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team. Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency. Support key department and enterprise level initiatives as part of the IRT representative. Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high -risked areas and new functionality documented in the user requirements. Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes. Ensure effective system access and functionality across all countries and all user locations. Support unblinding activities as needed. Ensure on time development of IRT data transfers with vendors and/or third-party vendors. Ensure eTMF compliance at the study level in accordance with group and BMS guidance. Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms. Supporting People with Disabilities Minimum bachelor's degree Minimum of 3 to 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint. Clinical Research experience Working knowledge of IRT Working knowledge of Clinical Trial Management Systems Working knowledge of clinical supplies Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio. Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards. Exposure to working in a GMP / GCP environment and with regulatory audit teams. Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required Comfortable working with a global team, partners and customers in a change agile environment MS Project, MS Visio, or any other requirements visualization and analysis tools)
About the Role/Company
- Supports UAT Services organization as required
- Part of the IRT Team and involved in key department and enterprise level initiatives
Key Responsibilities
- Lead successful maintenance support and projects to ensure on-time delivery of Interactive Response Technology (IRT) changes, data, and support integrations with other clinical systems
- Ensure IRTs are fit-for-purpose as defined by protocol and study operational parameters with adherence to BMS standards and quality principles
- Work independently and assume support role responsibilities on assigned projects
- Collaborate with the IRT Team to ensure BMS standards and address requests by study teams that are not within these standards or best practice
- Generate and oversee patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements
- Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team
- Support IRT improvement initiatives and manage improvement projects that impact daily operations to improve efficiency
- Support key department and enterprise level initiatives as part of the IRT representative
- Ensure on-time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures
- Write or review User Acceptance Test Plan and causes to ensure thorough testing of high-risked areas and new functionality documented in the user requirements
- Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance with BMS SOPs and processes
- Ensure effective system access and functionality across all countries and all user locations
- Support unblinding activities as needed
- Ensure on-time development of IRT data transfers with vendors and/or third-party vendors
- Ensure eTMF compliance at the study level in accordance with group and BMS guidance
- Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms
Required Qualifications
- Minimum bachelor's degree
- to 5 years of work experience in health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.)
- Demonstrated analytical skills
- Working knowledge of Microsoft Office including SharePoint
- Working knowledge of IRT
- Working knowledge of Clinical Trial Management Systems
- Working knowledge of clinical supplies
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Excellent English language written and verbal communication skills
Preferred Qualifications
- Clinical Research experience
- Ability to think outside of the box
Skills Required
- Excellent communication skills
- Analytical skills
- Ability to deliver optimal IRT solutions across a diverse and dynamic portfolio
- Understanding of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
- Interpersonal, collaboration, and business partnership capabilities
- Comfortable working with a global team, partners, and customers in a change agile environment
- Proficiency in MS Project, MS Visio, or other requirements visualization and analysis tools
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
60,000 - 100,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Excellent communication skillsintermediate
- Analytical skillsintermediate
- Ability to deliver optimal IRT solutions across a diverse and dynamic portfoliointermediate
- Understanding of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standardsintermediate
- Interpersonal, collaboration, and business partnership capabilitiesintermediate
- Comfortable working with a global team, partners, and customers in a change agile environmentintermediate
- Proficiency in MS Project, MS Visio, or other requirements visualization and analysis toolsintermediate
Required Qualifications
- Minimum bachelor's degree (experience)
- to 5 years of work experience in health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) (experience)
- Demonstrated analytical skills (experience)
- Working knowledge of Microsoft Office including SharePoint (experience)
- Working knowledge of IRT (experience)
- Working knowledge of Clinical Trial Management Systems (experience)
- Working knowledge of clinical supplies (experience)
- Exposure to working in a GMP / GCP environment and with regulatory audit teams (experience)
- Excellent English language written and verbal communication skills (experience)
Preferred Qualifications
- Clinical Research experience (experience)
- Ability to think outside of the box (experience)
Responsibilities
- Lead successful maintenance support and projects to ensure on-time delivery of Interactive Response Technology (IRT) changes, data, and support integrations with other clinical systems
- Ensure IRTs are fit-for-purpose as defined by protocol and study operational parameters with adherence to BMS standards and quality principles
- Work independently and assume support role responsibilities on assigned projects
- Collaborate with the IRT Team to ensure BMS standards and address requests by study teams that are not within these standards or best practice
- Generate and oversee patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements
- Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team
- Support IRT improvement initiatives and manage improvement projects that impact daily operations to improve efficiency
- Support key department and enterprise level initiatives as part of the IRT representative
- Ensure on-time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures
- Write or review User Acceptance Test Plan and causes to ensure thorough testing of high-risked areas and new functionality documented in the user requirements
- Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance with BMS SOPs and processes
- Ensure effective system access and functionality across all countries and all user locations
- Support unblinding activities as needed
- Ensure on-time development of IRT data transfers with vendors and/or third-party vendors
- Ensure eTMF compliance at the study level in accordance with group and BMS guidance
- Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms
Tags & Categories