Clinical Data Specialist

As a Clinical Trial Associate at Novartis Healthcare Private Limited, you will play a crucial role in contributing to all aspects of global clinical trials to ensure the delivery of study outcomes within schedule, budget, quality/compliance, and performance standards. You may also have the opportunity to lead specific aspects of global clinical trials as a core member of the Clinical Trial Team. Your responsibilities include: - Contribute to all operational/clinical trial deliverables within the scope of your specific JD, ensuring adherence to timelines, budget, operational procedures, quality/compliance, and performance standards. - Oversee protocol development, CRF development, and Informed Consent Form development during study start-up activities. - Analyze capability and make recommendations for trial inclusion by identifying new sites for clinical trials. - Ensure proper handling of all study conduct and closeout activities, including site closeout, final drug accountability, and audit readiness of Trial Master File documentation. - Educate, implement, and ensure compliance with standards (SOPs) and best practices for clinical operations and clinical data review activities within assigned clinical trials and programs. - Report technical complaints, adverse events, and special case scenarios related to Novartis products promptly and distribute marketing samples as required. Your key performance indicators will include: - Timely, efficient, and quality execution of assigned trials and related activities within budget and in compliance with quality standards. - Proactive operational planning with effective contingency and risk mitigation plans. - Adherence to Novartis policy, guidelines, and external regulations. Minimum Requirements: - Work Experience in Operations Management, Project Management, Financial Management, and collaborating across boundaries. - Skills in Trial Planning and Feasibility, Over The Counter Product Development, Post Authorization Data Safety, Regulatory Strategy, and Clinical Trial Set-up, Management & Conduct. Language Requirement: English proficiency. Novartis is dedicated to helping people with diseases and their families through innovative science and a community of smart, passionate individuals like yourself. By collaborating, supporting, and inspiring each other, we aim to achieve breakthroughs that positively impact patients" lives. If you are ready to contribute to creating a brighter future, consider joining our Novartis Network to explore suitable career opportunities. To learn more about the benefits and rewards offered at Novartis Healthcare Private Limited, please refer to our handbook. Novartis is committed to fostering an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. Note: For any accessibility or accommodation needs during the recruitment process, including reasonable accommodations for individuals with disabilities, please contact [email protected] with your request and contact information, mentioning the job requisition number.,