We 9re hiring a Clinical Data Operations Manager to join Ro 9s Scientific Affairs teama small highreputed 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 operationscombining handson study execution with rigorous data review and analytics Your work will support sponsorfacing 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 companyworld care Operating reputed company GCP sponsor expectations and regulatory frameworks you 9ll play a key role in translating highreputed company data into insights that are trusted and actionable This is a role for someone who wants more than operational reputed company reputed companyit 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 evidencedriven leader in reputed company innovation If you 9re motivated by rigor reputed company and the chance to help define how reputed companyworld 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 pharmaceuticalsponsored 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 studyspecific SOPs monitoring plans and training materials Ensure study personnel training documentation is complete and auditreputed 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 sponsorapproved 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 CrossFunctional 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 sponsorfacing 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 57 years of experience in clinical research research operations or data operations reputed company a pharmaceutical company contract research organization CRO or reputed companysponsored research environment Handson 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 Solid analytical documentation and communication skills Preferred Qualifications Experience supporting reputed company observational studies or postmarketing research for pharmaceutical sponsors Experience building or validating dashboards in BI tools e g

📌 Clinical Data and Operations Manager Scientific Affairs (India)
🏢 remotepromsp
📍 India