ro - Clinical Data & Operations Manager, Scientific Affairs
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Requirements
• 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 • 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 • 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. • 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’ers 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).
Responsibilities
• 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
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