What are the responsibilities and job description for the Senior Consultant (Clinical Data Governance) position at The Fountain Group?
Details for the position are as follows:
- Rate: $65-75 an hour
- Location: 100% remote - candidates local to Basking Ridge, NJ able to come onsite occasionally preferred not required
- 5-month contract to start with the possibility of extension or conversion depending on performance and business needs
- 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 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.
- BS degree required.
- 12 years of experience needed.
- 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 Collibra platform.
Salary : $65 - $75