Clinical Data Governance Lead

• Work/Location Schedule: 37.5 hours per week; local NJ candidate preferred however qualified remote based candidate would be considered and need to be able to support EST hours.
• Initial Duration: 6 months, starting asap, may be extended
• Education: Bachelor's degree, preferably related to life sciences.
• Years of Experience: Minimum 15 years – comparable to a senior level/experienced Clinical Development Business Analyst/Data Analyst

Summary
Experienced, senior-level individual with strong experience in clinical development (clinical study lifecycle and clinical data lifecycle) required to assist with data governance initiatives, including business glossaries, data catalogs, metadata management, data lineage, master and reference data management, data quality, data policies, data controls, data sharing, data stewardship, etc.

Requires strong oral and written communication, expertise in analyzing clinical processes and data, experience meeting with and influencing senior-level leaders at all levels, adept at preparing and presenting high-quality presentations and leading workshops, and being a proactive, self-driven team player.

Responsibilities
Following are the immediate responsibilities of the position. This is expected to evolve over time in other areas of pharmaceutical data governance.

• Provide support for biostatisticians, translational scientists, researchers, and other clinical data analysts in the governance process for accessing clinical data (no biostatistics or translational science experience needed).
• Drive data stewardship for clinical studies, sites, investigators and products.
• Work with business functions to help define data definitions, standards and glossaries.
• Maintaining business glossaries and catalogs in Collibra for business functions.
• Drive adoption of governed data assets.
• Create and deliver high quality documentation and presentations.

Qualifications – Required

• Strong pharmaceutical and clinical background with deep understanding of clinical trial processes, study lifecycle, and regulated data environments.
• Deep understanding of clinical trial data lifecycle, data types, data usage, data management, related roles and responsibilities.
• Strong communication and stakeholder engagement skills, with the ability to explain data governance methodologies, standards, and business value to both technical and non-technical audiences.
• Ability to lead and influence governance discussions by facilitating workshops, gathering requirements, driving consensus on definitions and standards, and supporting adoption of governed clinical data assets across the organization.
• Very strong written and oral communication skills.

Qualifications – Strong Plus

• Experience with Master Data Management (MDM) to support the mastering and governance of critical clinical entities such as clinical studies, sites, investigators, and products.
• Experience with data sharing for secondary use of clinical study data.
• Strong knowledge of data governance principles and methodologies including data ownership, stewardship, and metadata management.
• Hands-on experience with defining business data glossaries (terms, definitions), data standards, data-related roles, data management/governance processes, etc.
• Experience with data quality, including defining data quality rules, monitoring data issues, tracking remediation, and establishing meaningful data quality measures and KPIs.
• Familiarity with enterprise data governance platforms such as Collibra or similar tools used for data catalogs, glossary management, data lineage, data stewardship.

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