Clinical Data & Operations Manager, Scientific Affairs

We 9re hiring a Clinical Data & Operations Manager to join Ro 9s Scientific Affairs team-a small, high-impact group of physicians, scientists, and data experts shaping how clinical credibility is built in modern healthcare. You 9ll 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 9ll collaborate closely with physicians, PhDs, and clinical experts who care deeply about scientific integrity and patient impact. Together, you 9ll 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 9ll 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 9s an opportunity to contribute to evidence that is consequential. Your work will influence partners, practitioners, and internal leadership, and help strengthen Ro 9s position as an evidence-driven leader in healthcare innovation. If you 9re 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 9ll 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 9ll Bring to the Team:

• [Required Qualifications]
• Bachelor 9s 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 9ve 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

> The target base salary for this position ranges from $133,500 - $159,000, in addition to a competitive equity and benefits package (as applicable). When determining compensation, we analyze and carefully consider several factors, including location, job-related knowledge, skills and experience. These considerations may cause your compensation to vary. Ro recognizes the power of in-person collaboration, while supporting the flexibility to work anywhere in the United States. For our Ro 9ers in the tri-state (NY) area, you will join us at HQ on Tuesdays and Thursdays. For those outside of the tri-state area, you will be able to join in-person collaborations throughout the year (i.e., during team on-sites). At Ro, we believe that our diverse perspectives are our biggest strengths - and that embracing them will create real change in healthcare. Apply tot his job Apply To this Job