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GSK India
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Principal Lead, Data Standards

Principal Lead, Data Standards

GSK India

5 - 10 years

8 - 9 Lacs

bengaluru

Posted:1 week ago| Platform:

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Skills Required

procurement cro data management clinical trials oncology life sciences asset management risk management medical writing technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Principal Lead, Data Standards will lead and/or support cross-functional teams in maintaining and enhancing global analysis and reporting data standards, ensuring innovation, compliance, and alignment with Standard Governance. As a key Subject Matter Expert in analysis & reporting standards such as CDISC ADaM, this role will contribute to the development of high-quality data standards, provide guidance to team members, and may include product ownership responsibilities for specific standards or tools.. Additionally, this position provides mentorship and supervision to team members.

In this role you will

Analysis and Reporting Standards Development and Management

Develop, manage, and optimize GSK-specific data standards, aligning with industry benchmarks (eg, CDISC), regulatory and scientific requirements to define custom standards, and creating supporting documentation in response to business needs.

Cross-Functional Collaboration

Coordinate and contribute to cross-functional teams across R&D functions (eg Clinical, Medical, Programming, Statistics, Data Management, Medical Writing, Regulatory and Safety) to establish core and therapeutic area standards and promote effective teamwork.

C ompliance and Risk Management

Ensure adherence to industry and regulatory data standards mandates, assess proposals and regulatory changes, conduct risk analysis, and implement necessary updates and corrective actions in response to audits for global data standards.

Process and Stakeholder Optimization

Contribute to the development and maintenance of process documents (SOPs, templates, best practices) and work with stakeholders to improve processes and technologies related to data standards maintenance and adoption.

Product Ownership

Serve as a product owner for specific data standards or tools, such as ADaM standards.
Oversee the lifecycle management of assigned products, ensuring they meet business needs and align with regulatory and scientific requirements.
Collaborate with stakeholders to prioritize product updates and enhancements.

Leadership and Oversight

Represent the organization in internal and external initiatives (eg, CDISC, PhUSE), manage matrix teams, and support talent development through coaching, mentoring, appraisals, and workload management. May also oversee and guide some activities delivered by our CRO partners.

Advocacy and Consultancy

Act as a champion for data standards across the organization, supporting stakeholder awareness, providing consultancy on data standards (core and therapeutic), and serving on cross-functional/external boards or project teams as needed.

Basic Qualifications & Skills:

bachelors degree in sciences, or equivalent functional industry experience, in Life Sciences, Computer Sciences, Mathematics and Physics or equivalent.
Proven experience over approximately 5+ years working in pharmaceutical industry/Clinical Trial, Clinical Programming with expertise in industry data standards (eg, CDISC) and deep understanding of analysis and reporting requirements for clinical trials.
Proven ability to analyse business problems/opportunities within at least one of the data stewardship areas (eg, asset management, data standards, life cycle management and provision of assets).
Track record of developing and delivering high quality solutions / deliverables.
Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc) to audiences with varied and sometimes limited technical knowledge.
Excellent record of customer focus, influence, delivery, innovation, follow through and acting as a catalyst for change.

Preferred Qualifications & Skills:

masters Degree in Sciences, or equivalent functional industry experience, in Life Sciences, Computer Sciences, Mathematics and Physics or equivalent.
Programming or data science experience is preferable.
Experience mentoring, coaching and/or guiding matrix teams working on analysis and reporting standards.
Experience of agile project management.

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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Principal Lead, Data Standards