Senior Clinical Data Governance Consultant

Source One is a consulting services company and we’re currently looking for the following individual to work as a remote consultant to our direct client, a global pharmaceutical company in Basking Ridge, NJ.

* We are unable to work with third party companies for this role.

Job Title: Senior Clinical Data Governance Consultant (Contract)

Pay Range: $90/hr - $110/hr (W-2)

Work Schedule: Remote but must be able to work EST hours; will occasionally participate in meetings as early as 7am and as late as 8pm (EST).

Summary: The Center for Data Governance (CFDG) group is responsible for strategy and initiatives that lead to trust in the data, ability to use the data effectively, and better business outcomes.

The Senior Consultant (Clinical DG) will be a key member of a small data governance team and will primarily assist with democratizing clinical data sharing through a governed data sharing framework, mastering clinical data, data harmonization, and expanding the use of AI in data governance. This is an individual contributor position, but with very senior-level responsibilities that require significant previous leadership experience and strong experience with clinical trial data and analysis in the pharmaceutical domain. As such, the candidate will need to take on numerous hands-on and administrative responsibilities as well as contribute to thought leadership, strategy, and vision, and work with collaborators and stakeholders at all levels and across multiple functions, geographical regions, and time zones (primarily Japan and Europe).

The CFDG has embraced the AI/GenAI revolution (albeit with caution and commonsense) and this position offers an exciting opportunity to learn and apply GenAI concepts for routine tasks, documents creation, operational improvements, and other advanced innovations (e.g., ICF analysis) across DG administration, operations, and solutions.

Data Sharing: The primary responsibility of the position will be to operate and maintain a data governance framework that supports sharing of clinical trial data. Specific responsibilities include maintaining a data catalog, managing the data access request process, understanding operational and governance implications of data requests (e.g., data privacy, GxP-compliance, statistical analysis tools), educating and guiding biostatisticians and clinical data analysts (and teams) in the use of the data sharing framework, collaborating with Biostatistics, Data Management, Precision Medicine, and other stakeholders at all levels, and creating and maintaining related offline and online documentation and information (presentations, policy documents, user guides, etc.). This position is not required to perform any statistical data analysis but will need to 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. This position will eventually be expected to independently lead the data sharing initiative with minimal oversight.

Skills:

- Strong pharmaceutical and clinical background (development or research, ideally in oncology) with 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, related roles and responsibilities.

- Good understanding of governance concepts such as CSV, GxP, Legal, Privacy, and Compliance.

- Strong communication and stakeholder engagement skills, organizationally adept, ability to lead and influence by facilitating workshops, gathering requirements, leading discussions, and driving consensus across a global and 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 concepts of GenAI, ability and strong desire to learn and use GenAI and other AI-based techniques and methods to improve processes; AI/GenAI development-level knowledge is not needed.

- Self-driven, self-starter and self-management exemplar; ability to create, manage, and report on own mini-projects and “book of work” and lead/guide/influence others as needed.

- Strong nice-to-have: prior direct/hands-on experience with data sharing frameworks; data analysis skills using SQL and/or statistical languages and platforms; understanding of data governance principles such as data anonymization/pseudonymization; data ownership, data stewardship, data standards, policies, metadata, business glossaries and controlled vocabularies; process design; understanding of clinical and operational data quality;

- Nice-to-have: understanding of master data management; experience with the Collibra platform.

Additional responsibilities may include:

- Data Mastering: This initiative seeks to match and merge clinical data sources to create a single, centralized, trusted source of data for clinical studies, sites, and investigators. This position will be a contributor to this initiative and will need to provide subject matter expertise in clinical operations (e.g., data standards and guidelines for protocol IDs, site and addresses, and investigators), contribute to AI-driven solution designing and testing, analyze related data using tools such Excel, and related activities.

- Data Harmonization: The ultimate goal of data harmonization is to improve data quality by standardizing reference data and controlled vocabularies (e.g., study type, study phase, therapeutic area) and harmonizing it across business processes and systems, but that happens across multiple functions and teams. The Data Governance group is focused on governance-related activities, and specific responsibilities include creating controlled vocabularies, defining (and providing guidance in the creation of) related data standards, policies, and rules, and working with business and systems teams to adopt controlled vocabularies and data standards.

Required:

Education: Minimum Bachelor’s degree, preferably related to bioinformatics/life sciences

Years of experience: Minimum 12 years