Senior Consultant (Clinical Data Governance)

About the role

This is a 100% remote position (occasional onsite work in Basking Ridge, NJ preferred but not required) with an initial 5‑month contract, with the possibility of extension or conversion based on performance and business needs.

Responsibilities

• Operate and maintain a data governance framework that supports sharing of clinical trial data.
• Maintain the data catalog.
• Manage the data access request process.
• Understand operational and governance implications of data requests (e.g., data privacy, GxP‑compliance, statistical analysis tools).
• Educate and guide biostatisticians, clinical data analysts, and their teams in the use of the data sharing framework.
• Collaborate with Biostatistics, Data Management, Precision Medicine, and other stakeholders at all levels and across multiple functions, geographical regions, and time zones (primarily Japan and Europe).
• Create and maintain related offline and online documentation and information (presentations, policy documents, user guides, etc.).
• Work closely with biostatisticians and data analysis/management experts, as well as governance leaders in areas such as pharmaceutical QA (CSV), Legal, and Privacy/Compliance.
• Eventually expected to independently lead the data sharing initiative with minimal oversight.

Qualifications

• BS degree required.
• 12+ years of relevant experience.
• Strong pharmaceutical and clinical background (development or research), ideally in oncology.
• Deep understanding of clinical trial processes, study lifecycle, and regulated data environments.
• Deep understanding of clinical data structures (CDIS/SDTM/ADAM), clinical trial data lifecycle, data types, data usage, data management, and related roles and responsibilities.
• Good understanding of governance concepts such as CSV, GxP, Legal, Privacy, and Compliance.

Skills

• Strong communication and stakeholder engagement skills; organizationally adept, able to lead and influence by facilitating workshops, gathering requirements, leading discussions, and driving consensus across a global, multi‑cultural organization.
• Very strong written and oral communication skills; ability to create, deliver, and maintain high‑quality documentation and presentations.
• Good grasp of basic GenAI concepts; strong desire to learn and use GenAI and other AI‑based techniques to improve processes (development‑level AI knowledge not required).
• Self‑driven, self‑starter, and self‑management exemplar; able to create, manage, and report on own mini‑projects and “book of work” and to lead, guide, or influence others as needed.
• Nice‑to‑have: prior direct/hands‑on experience with data sharing frameworks.
• Nice‑to‑have: data analysis skills using SQL and/or statistical languages and platforms.
• Nice‑to‑have: understanding of data governance principles such as data anonymization/pseudonymization, data ownership, data stewardship, data standards, policies, metadata, business glossaries, and controlled vocabularies.
• Nice‑to‑have: process design knowledge; understanding of clinical and operational data quality.
• Nice‑to‑have: understanding of master data management.
• Nice‑to‑have: experience with the Collibra platform.

Pay

Rate: $65‑75 per hour.