Data Operations Domain Lead, Global Development & Regulatory IT
The Data Operations Domain Lead is a critical leadership role within the Life Cycle Management & Operations (LCMO) group in Global Development & Regulatory IT (GDRIT), focused on application maintenance and support for clinical data management applications supporting the Global Development Operations (GDO) business function.
The Domain Lead has accountability for all life cycle management and operations activities within the Data Operations domain, including demand management, release management, and operational support including inspection/audit support.
Responsibilities:
Manage all maintenance and support work for R&D clinical data management applications, working collaboratively to optimize application enhancement and support investment Ensure a fully aligned and business-approved Data Operations maintenance portfolio per incremental release cycle, building more structured, strategic, and aligned relationships with GDO stakeholders Support the demand management process by conducting Business System Working Group (BSWG) meetings to review and prioritize proposed changes, reviewing development estimates, and providing guidance to business capability leads to optimize the release planning process through efficient bundling of enhancements, design and architecture considerations, etc.
Complete business analyst/UAT Lead work for application maintenance releases, ensuring appropriate requirements are gathered and appropriate user acceptance testing is completed Provide oversight to Tier 3 to ensure delivery of maintenance commitments, critical releases, and other approved changes according to agreed time, budget, scope and quality Deliver quality components at each phase of the development cycle (e.
g.
, requirements specification, UAT) and ensure the new functionality can be supported by Tier 1/2/3 at resource levels commensurate with the maintenance budget Ensure timely coordination and delivery of critical defect fixes based on business need Ensure effective delivery of infrastructure-related upgrades according to schedule Deliver operational support activities for clinical data management applications, including effective and timely ticket triage, communication, and resolutionEnsure timely coordination and support to address 100% of regulatory compliance inspection findings Effectively transition new capabilities into steady-state operations Ensure Tier 2/3 support capacity is managed with clarity and rigor Qualifications The successful candidate will have:
BS/BA in Engineering, Computer Science or Life Sciences (or other quantitative related discipline).
Masters or other advanced degree is a plus.
At least seven (7) years experience, with four (4) or more in the pharma/biotech industryBroad technology and implementation experience, strong working knowledge of Pharmaceutical R&D business functions (clinical data management experience is required), demonstrated project management skills, the ability to drive performance, achieve results, and effectively manage relationships in a highly matrixed organizationExperience implementing and supporting the Oracle Life Sciences suite of products (specifically Oracle Clinical, RDC, LSH, CDA) Excellent communication, interpersonal, negotiation, influencing, networking and facilitation skills are also essential Experience implementing complex technical solutions, leading cross-functional teams, and developing applications following structured SDLC processes in a regulated environment Experience working with offshore software development models Experience in business analysis, requirements specifications, and portfolio planning, with high degree of organization and the ability to prioritize and schedule multiple workloads Ability to achieve successful consensus among differing priorities and stakeholders in both the IT and Business communities Proven track record in effective cross-functional, multi-site, matrixed environments Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502285.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Domain Lead has accountability for all life cycle management and operations activities within the Data Operations domain, including demand management, release management, and operational support including inspection/audit support.
Responsibilities:
Manage all maintenance and support work for R&D clinical data management applications, working collaboratively to optimize application enhancement and support investment Ensure a fully aligned and business-approved Data Operations maintenance portfolio per incremental release cycle, building more structured, strategic, and aligned relationships with GDO stakeholders Support the demand management process by conducting Business System Working Group (BSWG) meetings to review and prioritize proposed changes, reviewing development estimates, and providing guidance to business capability leads to optimize the release planning process through efficient bundling of enhancements, design and architecture considerations, etc.
Complete business analyst/UAT Lead work for application maintenance releases, ensuring appropriate requirements are gathered and appropriate user acceptance testing is completed Provide oversight to Tier 3 to ensure delivery of maintenance commitments, critical releases, and other approved changes according to agreed time, budget, scope and quality Deliver quality components at each phase of the development cycle (e.
g.
, requirements specification, UAT) and ensure the new functionality can be supported by Tier 1/2/3 at resource levels commensurate with the maintenance budget Ensure timely coordination and delivery of critical defect fixes based on business need Ensure effective delivery of infrastructure-related upgrades according to schedule Deliver operational support activities for clinical data management applications, including effective and timely ticket triage, communication, and resolutionEnsure timely coordination and support to address 100% of regulatory compliance inspection findings Effectively transition new capabilities into steady-state operations Ensure Tier 2/3 support capacity is managed with clarity and rigor Qualifications The successful candidate will have:
BS/BA in Engineering, Computer Science or Life Sciences (or other quantitative related discipline).
Masters or other advanced degree is a plus.
At least seven (7) years experience, with four (4) or more in the pharma/biotech industryBroad technology and implementation experience, strong working knowledge of Pharmaceutical R&D business functions (clinical data management experience is required), demonstrated project management skills, the ability to drive performance, achieve results, and effectively manage relationships in a highly matrixed organizationExperience implementing and supporting the Oracle Life Sciences suite of products (specifically Oracle Clinical, RDC, LSH, CDA) Excellent communication, interpersonal, negotiation, influencing, networking and facilitation skills are also essential Experience implementing complex technical solutions, leading cross-functional teams, and developing applications following structured SDLC processes in a regulated environment Experience working with offshore software development models Experience in business analysis, requirements specifications, and portfolio planning, with high degree of organization and the ability to prioritize and schedule multiple workloads Ability to achieve successful consensus among differing priorities and stakeholders in both the IT and Business communities Proven track record in effective cross-functional, multi-site, matrixed environments Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502285.
Estimated Salary: $20 to $28 per hour based on qualifications.
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