Job Title: Research Associate in Clinical Management
Job Summary
We are seeking a dynamic, independent, and experienced Research Associate in Clinical Management. The role involves processing, reviewing, and managing clinical data and records from various sources. Ensuring accurate, timely, and consistent data is crucial for our clinical teams and other groups.
Responsibilities
- Facilitate Study Start-up activities at Clinical Investigational Sites
- Conduct Feasibility and assess data
- Conduct site qualification visits to assess site suitability
- Collect essential documents for regulatory and EC submissions
- Identify training needs for site staff
- Ensure supply of clinical trial material to sites before study initiation
Clinical Site Management
- Initiate studies at clinical sites
- Provide study protocol and related training
- Review Informed Consent forms and narratives
- Review source records and perform SDV
- Review CRF data entry and resolve data queries
- Ensure timely completion and review of site visit reports
- Manage IP accountability and reconciliation
- Ensure compliance with protocol, SOPs, GCP, and regulatory requirements
- Support audits, inspections, and QC visits
Site Contracts and Payment Coordination
- Coordinate CDA, Clinical Trial Agreements, and amendments
- Ensure site invoices are generated and processed as per agreement
- Perform reconciliation of payments against site activities
Vendor and Stakeholder Liaison
- Coordinate with safety labs for timely sample processing
- Liaise with internal project teams and external stakeholders
- Ensure compliance with study plans, SOPs, GCP, and regulatory requirements
Trial Master File Review and Maintenance
- Ensure timely updating and retrieval of documents for filing
- Review onsite and in-house files for inspection readiness
Qualifications
- Master’s degree in Pharmacy, Life Science, Biology, Biotechnology, Biochemistry, or a Diploma in Clinical Research
- 2-5 years of research experience
Skills and Attributes
Technical Skills
- Experience in Clinical Trial operations
- Proficiency in market research and analysis
- Knowledge of GCP and ICH guidelines
- Ability to evaluate medical research data
- Proficiency in EDC systems and MS Office
Behavioral Skills
- Excellent communication, negotiation, and interpersonal skills
- Strong project management, analytical, and problem-solving abilities
- Detail-oriented and result-driven
About the Department
The Integrated Product Development Organisation at Dr. Reddy’s focuses on developing innovative, accessible, and affordable therapies. We serve over 55 markets with a robust R&D team of over 200 scientists and functional experts, having filed 1,071 patents and published over 1,000 peer-reviewed papers.
Benefits
- Personalized learning programs for career growth
- Competitive industry-standard benefits including joining & relocation support, family support, learning and development opportunities, and medical and life coverage
Work Culture
At Dr. Reddy’s, our guiding principle is “Good Health Can’t Wait.” We foster a culture of empathy and dynamism, supporting individual abilities while promoting teamwork and shared success. We believe in empowering people to stay fit and lead healthier lives through our healthcare solutions.
For more details, visit our career website: Dr. Reddy’s Careers
