Job Description
Details for the position are as follows:
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- 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.
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By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
Numbers & Facts
| Location | Basking Ridge, NJ (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $65–$75 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
- Administrative Skillsunmatched
- Analysis Skillsunmatched
- Artificial Intelligence (AI)unmatched
- Biostatisticsunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Assessmentunmatched
- Clinical Dataunmatched
- Clinical Supportunmatched
- Clinical Trialunmatched
- Communication Skillsunmatched
- Consultingunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Data Managementunmatched
- Data Qualityunmatched
- Documentationunmatched
- Drug Developmentunmatched
- GxPunmatched
- Leadershipunmatched
- Legalunmatched
- Master Data Management (MDM)unmatched
- Medicineunmatched
- Metadataunmatched
- Multiculturalunmatched
- Oncologyunmatched
- Online Publicationsunmatched
- Operations Processesunmatched
- Pharmaceutical Analysisunmatched
- Presentation/Verbal Skillsunmatched
- Process Improvementunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Requirements Managementunmatched
- SQL (Structured Query Language)unmatched
- Statisticsunmatched
- Stewardshipunmatched
- Thought Leadershipunmatched
- Writing Skillsunmatched
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