We’re hiring a Clinical Data & Operations Manager to join Ro’s Scientific Affairs team—a small, high-impact group of physicians, scientists, and data experts shaping how clinical credibility is built in modern healthcare.
You’ll work at the intersection of clinical science, data, and operations—combining hands-on study execution with rigorous data review and analytics. Your work will support sponsor-facing monitoring, source data verification, and reporting, ensuring studies meet the highest standards of quality, transparency, and regulatory rigor.
You’ll collaborate closely with physicians, PhDs, and clinical experts who care deeply about scientific integrity and patient impact. Together, you’ll generate evidence that fills critical gaps left by traditional trials and informs how therapies are evaluated and used in real-world care. Operating within GCP, sponsor expectations, and regulatory frameworks, you’ll play a key role in translating high-quality data into insights that are trusted and actionable.
This is a role for someone who wants more than operational excellence alone—it’s an opportunity to contribute to evidence that is consequential. Your work will influence partners, practitioners, and internal leadership, and help strengthen Ro’s position as an evidence-driven leader in healthcare innovation.
If you’re motivated by rigor, impact, and the chance to help define how real-world evidence is generated and applied at scale, this role was built for you.
What You'll Do:
Study Operations & Regulatory Compliance
Support execution of pharmaceutical-sponsored studies in accordance with approved protocols, SOPs, GCP, and applicable regulatory requirements
Maintain accurate study enrollment records, participant identifiers, and operational logs suitable for sponsor review
Support reconciliation between participant lists and safety, efficacy, and operational data sources
Prepare documentation and data outputs for sponsor monitoring, audits, and inspections
Support maintenance and updates of study-specific SOPs, monitoring plans, and training materials
Ensure study personnel training documentation is complete and audit-ready
Data Monitoring, Source Data Verification (SDV) & Analytics
Perform source data verification (SDV) and data quality checks consistent with sponsor and CRO expectations
Independently write and review SQL queries to extract, reconcile, and validate study datasets against source systems
Identify data discrepancies, trends, and protocol deviations; document findings and support resolution per established procedures
Partner with Data Analytics to define sponsor-approved monitoring metrics and KPIs (e.g., enrollment, retention, safety signals, deviations)
Contribute to the design, build, validation, and maintenance of study monitoring dashboards used for internal oversight and sponsor reporting
Support ad hoc sponsor data requests and feasibility or exploratory analyses
Reporting & Documentation
Prepare study monitoring outputs, reconciliation logs, and SDV summaries for internal and sponsor use
Support interim and final study reports by validating underlying datasets and analyses
Document data review methodologies, assumptions, and validation steps to support traceability and audit readiness
Cross-Functional Collaboration
Serve as a liaison between Scientific Affairs, Enterprise Data, and pharmaceutical or CRO partners
Translate sponsor and protocol requirements into data specifications and monitoring logic
Escalate data quality, compliance, or operational risks to study leadership promptly
Contribute to continuous improvement of sponsor-facing monitoring and data oversight processes
What You’ll Bring to the Team:
Required Qualifications
Bachelor’s degree in health sciences, life sciences, statistics, data science, or a related field, or equivalent experience
5-7 years of experience in clinical research, research operations, or data operations within a pharmaceutical company, contract research organization (CRO), or pharma-sponsored research environment
Hands-on experience supporting sponsor monitoring, SDV, or data reconciliation activities
Strong working knowledge of SQL and experience querying relational databases for study monitoring and validation
Familiarity with GCP, ICH guidelines, and sponsor expectations for data quality and documentation
Strong analytical, documentation, and communication skills
Preferred Qualifications
Experience supporting RWE, observational studies, or post-marketing research for pharmaceutical sponsors
Experience building or validating dashboards in BI tools (e.g., Hex)
Experience working with safety data, lab data, EHR-derived data, or patient-reported outcomes
Prior experience interacting directly with sponsors, CROs, or monitors during audits or data reviews
Compliance & Training
Completion of required GCP and human subjects protection training prior to study involvement, with re-certification as required
We've Got You Covered:
Full medical, dental, and vision insurance + OneMedical membership
Healthcare and Dependent Care FSA
401(k) with company match
Flexible PTO
Wellbeing + Learning & Growth reimbursements
Paid parental leave + Fertility benefits
Pet insurance
Student loan refinancing
Virtual resources for mindfulness, counseling, and fitness
We welcome qualified candidates of all races, creeds, genders, and sexuality to apply.
