Job Summary

We are seeking a dynamic independent and experienced Central Monitor / Senior Central Monitor to oversee centralized clinical data review across therapeutic areas. The role focuses on proactive analysis of clinical data trends to ensure data quality subject safety and protocol compliance using risk-based monitoring.

The candidate will review and integrate data from multiple sources (EDC labs safety vendors) and deliver timely accurate insights to stakeholders.

Working closely with cross-functional teams the role will identify risks detect anomalies and support issue resolution driving quality improvements in line with RBQM and regulatory standards.

Roles & Responsibilities

Key Responsibilities

1. Perform ongoing centralized (remote) monitoring of clinical trial data using multiple data sources (e.g. EDC subject visits central labs vendors) to ensure data integrity consistency and subject safety. Identify data trends anomalies entry patterns and risk signals related to quality safety efficacy and site performance.
2. Enable early identification of risks and issues during study conduct generate risk alerts and ensure timely escalation to stakeholders (Lead CM Project Lead Clinical Operations Lead CRAs).
3. Support on-site monitors (CRAs) by providing actionable insights on subject/site-specific risks and pending actions to enhance the effectiveness and focus of monitoring visits.
4. Document all central monitoring activities including risk identification escalation tracking and resolution ensuring traceability and inspection readiness.
5. Collaborate with cross-functional teams (Clinical Operations Data Management Safety Medical Vendors) to manage subject site and study-level issues.
6. Contribute to the development and maintenance of Key Risk Indicators (KRIs) and ensure alignment with study-specific and standardized risk frameworks.
7. Perform advanced analytical reviews to focus on critical data impacting subject safety and study outcomes including root cause analysis and systematic issue resolution.
8. Liaise with external vendors and investigational sites to support timely resolution of data and operational queries.
9. Identify protocol deviations process gaps and compliance risks escalate appropriately and support CAPA development implementation and effectiveness checks.
10. Participate in study team meetings risk review meetings and cross-functional discussions as required.
11.



Support audits inspections and quality control activities ensuring readiness and adherence to regulatory expectations.
12. Perform periodic review of study documentation and TMF to ensure completeness accuracy and continuous inspection readiness.

Qualifications :

Educational qualification: Masters degree in Pharmacy Life Sciences Biology Biotechnology or Biochemistry from a recognized institution; Diploma/Certification in Clinical Research is an added advantage.

Skills & Attributes

Technical Skills

- Strong hands-on experience with EDC systems (e.g. Oracle Medidata Rave) for data review and query tracking
- Proficiency in central monitoring / RBQM tools (e.g. dashboards KRI/QTL tracking statistical monitoring platforms)
- Ability to perform data analytics and trend analysis using tools such as Excel (advanced) Power BI Spotfire or similar visualization platforms
- Expertise in risk indicators (KRI) Quality Tolerance Limits (QTLs) and signal detection
- Knowledge of data reconciliation processes (lab SAE vendor data)
- Understanding of protocol review CRF design linkage and edit checks
- Familiarity with CTMS eTMF systems and inspection readiness requirements
- Basic understanding of statistical concepts used in central monitoring (outliers distributions trends)

Preferred Qualifications & Experience

- 68 years of clinical research experience including CRA (on-site monitoring) and Central Monitoring experience
- Strong understanding of RBQM principles ICH E6(R2/R3) and GCP guidelines
- Experience in multi-source data review and risk-based monitoring strategies
- Strong analytical thinking risk assessment and root cause analysis skills
- Excellent communication and cross-functional collaboration abilities

Behavioural/ Core Attributes

- Proactive and risk-focused mindset
- Attention to detail with quality-driven approach
- Ability to prioritize and manage multiple studies/tasks
- Strong stakeholder management and influencing skills

Additional Information :

About the Department
Biologics




Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and current modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

No

Employment Type :

Full-time

📌 Central Monitor (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad