Dr. Reddy's Laboratories
Website:
drreddys.com
Job details:
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
Job Description
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
- 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.
- 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).
- 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.
- Document all central monitoring activities, including risk identification, escalation, tracking, and resolution, ensuring traceability and inspection readiness.
- Collaborate with cross-functional teams (Clinical Operations, Data Management, Safety, Medical, Vendors) to manage subject, site, and study-level issues.
- Contribute to the development and maintenance of Key Risk Indicators (KRIs) and ensure alignment with study-specific and standardized risk frameworks.
- Perform advanced analytical reviews to focus on critical data impacting subject safety and study outcomes, including root cause analysis and systematic issue resolution.
- Liaise with external vendors and investigational sites to support timely resolution of data and operational queries.
- Identify protocol deviations, process gaps, and compliance risks, escalate appropriately, and support CAPA development, implementation, and effectiveness checks.
- Participate in study team meetings, risk review meetings, and cross-functional discussions as required.
- Support audits, inspections, and quality control activities, ensuring readiness and adherence to regulatory expectations.
- Perform periodic review of study documentation and TMF to ensure completeness, accuracy, and continuous inspection readiness.
Qualifications
Educational qualification: Master’s 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
- 6–8 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 10–15-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 new 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 900,000 patients having benefited from our products till date.
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/
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