Bristol Myers Squibb
2 weeks ago
- Manages IRT for multiple studies (system development, vendor oversight, change management, data provisioning). -Supports UAT Services organization as required.- Identifies areas of process improvement and participates or leads these initiatives. Position Responsibilities:- Lead successful execution and on time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems ( 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.- Lead IRT projects as a strategic partner and single point of accountability to partner lines for IRT protocol assessments, requirements elicitation, system deployments, and resupply.- Work independently and assume decision making responsibilities on assigned projects.- Collaborate with the IRT Leadership 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.- Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.- Maintain vendor performance quality events in ADI log.- Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency.- Support key department and enterprise level initiatives as the IRT representative.- Responsible for generation an oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements.- Distribute patient randomization and container schedules as appropriate to Clinical Supply Operations and IRT vendors. -Participate in IRT vendor relationships and oversight to ensure delivery of IRT systems and seamless services; as well as, foster a collaborative relationship.- Consult and ensure on time delivery of user acceptance testing of IRT systems consistent with BMS SOPs and procedures.- This includes fostering collaboration and best practices with the IT QA organization.- 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.- Ensure on time development of IRT data transfers with vendors and/or third-party vendors.- During IRT Maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor.- Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved.- Support all unblinding activities.- Ensure eTMF compliance at the study level in accordance with group and BMS guidance.- Engage and support study and CSMT project teams as deemed necessary.- Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms.- Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.Experience Requirements:- Minimum of 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. (ref:iimjobs.com)
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Bristol Myers Squibb
2 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us- Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Bristol Myers Squibb
5 days ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us. Challenging. Meaningful. Life-changing.- Those aren't words that are usually associated with a job.- But working at Bristol Myers Squibb is anything but usual.- Here, uniquely interesting work happens every day, in every department.- From optimizing a production line to the latest breakthroughs in cell therapy, this is work that...
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Bristol Myers Squibb
4 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeDescription:- Working with Us.- Challenging.- Meaningful.- Life-changing.- Those aren't words that are usually associated with a job.- But working at Bristol Myers Squibb is anything but usual.- Here, uniquely interesting work happens every day, in every department.- From optimizing a production line to the latest breakthroughs in cell therapy, this is...
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Bristol Myers Squibb
4 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us.- Challenging.- Meaningful.- Life-changing.- Those aren't words that are usually associated with a job.- But working at Bristol Myers Squibb is anything but usual.- Here, uniquely interesting work happens every day, in every department.- From optimizing a production line to the latest breakthroughs in cell therapy, this is work that...
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Bristol Myers Squibb
4 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us. Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Bristol Myers Squibb
1 day ago
Hyderabad, India Bristol Myers Squibb Full timeManager - Biospecimen Working with Us.- Challenging.- Meaningful.- Life-changing.- Those aren't words that are usually associated with a job.- But working at Bristol Myers Squibb is anything but usual.- Here, uniquely interesting work happens every day, in every department.- From optimizing a production line to the latest breakthroughs in cell therapy,...
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Bristol Myers Squibb
3 days ago
Hyderabad, India Bristol Myers Squibb Full timearen't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do...
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Bristol Myers Squibb
5 days ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Bristol Myers Squibb
4 weeks ago
Hyderabad, India Bristol Myers Squibb Full timewith aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do...
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Bristol Myers Squibb
4 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeDescription : - Working with Us.- Challenging.- Meaningful.- Life-changing.- Those aren't words that are usually associated with a job.- But working at Bristol Myers Squibb is anything but usual.- Here, uniquely interesting work happens every day, in every department.- From optimizing a production line to the latest breakthroughs in cell therapy, this...
