Title: Clinical Domain Consultant
Location: NJ/MD/CA
JD:
Role Overview
We are seeking an experienced Clinical Domain Consultant with strong expertise in the Pharmaceutical and Life Sciences clinical domain. The ideal candidate will have hands-on experience across clinical development and clinical trial operations and will serve as a bridge between business stakeholders, clinical teams, data teams, and technology teams.
The consultant will help translate complex clinical business requirements into scalable data, analytics, technology, and digital solutions while supporting clinical transformation initiatives.
Key Responsibilities
- Provide subject matter expertise across Clinical Development and Clinical Trial Operations.
- Partner with Clinical Operations, Clinical Data Management, Biostatistics, Regulatory, Safety, and R&D stakeholders.
- Analyze and document current-state clinical processes, workflows, and business requirements.
- Identify opportunities to improve clinical processes through data, technology, automation, and AI.
- Translate business requirements into functional requirements, user stories, process flows, and solution specifications.
- Support the design and implementation of clinical technology and data solutions.
- Work with technology teams to ensure solutions align with clinical business needs.
- Support clinical data integration, data quality, governance, and standardization initiatives.
- Provide expertise across clinical trial processes, including:
- Study startup and planning
- Site and investigator management
- Patient recruitment and enrollment
- Clinical data collection
- Clinical trial monitoring
- Clinical data management
- Study closeout
- Clinical reporting and analytics
- Collaborate with data and technology teams working with EDC, CTMS, eTMF, RTSM/IWRS, Safety, Laboratory, and other clinical systems.
- Facilitate workshops with business and technical stakeholders.
- Support UAT, validation, implementation, and change management activities.
- Develop process documentation, requirements, business cases, and solution recommendations.
- Identify opportunities to leverage AI/ML, advanced analytics, cloud platforms, and automation within clinical operations.
- Communicate project status, risks, dependencies, and recommendations to stakeholders and leadership.
- Mentor junior consultants and contribute to clinical domain knowledge development.
Required Qualifications
- 8 12+ years of experience in the Pharmaceutical, Biotechnology, CRO, or Life Sciences industry.
- Strong knowledge of Clinical Operations and Clinical Trial processes.
- Experience working across the clinical development lifecycle.
- Strong understanding of clinical data and clinical technology ecosystems.
- Experience gathering and translating business requirements into technology solutions.
- Strong business analysis, process mapping, and problem-solving skills.
- Experience working in a consulting or client-facing environment.
- Excellent communication and stakeholder management skills.
- Ability to work effectively with both business and technical teams.
Preferred Skills
Experience with one or more of the following:
- Veeva Vault / Veeva Clinical
- Medidata Rave
- Oracle Clinical
- CTMS
- EDC
- eTMF
- RTSM / IRT / IWRS
- Clinical Data Management
- Clinical Trial Analytics
- Pharmacovigilance / Safety
- Clinical Data Standards
- CDISC / SDTM / ADaM
- Data Governance and Data Quality
- Cloud platforms AWS, Azure, or Google Cloud Platform
- Data & Analytics platforms
- AI/ML and Generative AI applications in Life Sciences
Key Competencies
Clinical Operations | Clinical Trials | Clinical Development | Life Sciences | Pharmaceutical R&D | Clinical Data | Business Analysis | Data & Analytics | Clinical Systems | Data Governance | AI/ML | Automation | Consulting | Stakeholder Management
Ideal Candidate
The ideal candidate is a Clinical Domain SME and consultant who understands clinical operations deeply and can bridge the gap between clinical business requirements, data, and technology. They should be comfortable working with senior stakeholders and leading discussions that translate clinical challenges into practical, scalable solutions.
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