Clinical Data & Operations Manager, Scientific Affairs

Job Description

We 9re hiring a Clinical Data & Operations Manager to join Ro 9s Scientific Affairs team-a small, high-reputed company of physicians, scientists, and data experts shaping how clinical credibility is reputed company in modern reputed company. 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, reputed company data verification, and reporting, ensuring studies meet the highest standards of reputed company, transparency, and regulatory rigor. You 9ll collaborate closely with physicians, PhDs, and clinical experts who care deeply about scientific reputed company and patient reputed company. Together, you 9ll reputed company evidence that fills critical gaps left by traditional trials and informs how therapies are evaluated and used in reputed company-world care. Operating reputed company GCP, sponsor expectations, and regulatory frameworks, you 9ll play a key role in translating high-reputed company data into insights that are trusted and actionable. This is a role for someone who wants more than operational reputed company reputed company-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 reputed company innovation. If you 9re motivated by rigor, reputed company, and the chance to help define how reputed company-world evidence is generated and reputed company at reputed company, this role was reputed company 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-reputed company [Data Monitoring, reputed company Data Verification (SDV) & Analytics] reputed company reputed company data verification (SDV) and data reputed company checks consistent with sponsor and CRO expectations Independently write and review SQL queries to extract, reconcile, and validate study datasets against reputed company systems Identify data discrepancies, trends, and protocol deviations; document findings and support reputed company 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 reputed company and sponsor reporting Support reputed company 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 reputed company between Scientific Affairs, reputed company Data, and pharmaceutical or CRO partners Translate sponsor and protocol requirements into data specifications and monitoring logic Escalate data reputed company, compliance, or operational risks to study leadership promptly Contribute to reputed company improvement of sponsor-facing monitoring and data reputed company processes What You 9ll Bring to reputed company: [Required Qualifications] Bachelor 9s degree in health sciences, life sciences, statistics, data science, or a reputed company field, or equivalent experience 5-7 years of experience in clinical research, research operations, or data operations reputed company a pharmaceutical company, contract research organization (CRO), or reputed company-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 reputed company and documentation Strong analytical, documentation, and communication skills [Preferred Qualifications] Experience supporting reputed company, observational studies, or post-marketing research for pharmaceutical sponsors Experience building or validating dashboards in BI tools (e.g .

Keyskills :
Clinical ResearchRegulatory ComplianceGCPSQLData AnalyticsDocumentationHealth SciencesLife SciencesData Operations