Job Title: Senior Clinical Research Associate – Mumbai, India
Category: Clinical Research / R&D
Experience Required: 5+ years in clinical trials as CRA
Location: Mumbai, Maharashtra | Full-Time
About Takeda
Takeda is a global, patient-focused biopharmaceutical company committed to advancing healthcare through innovative therapies. With a strong presence across India and worldwide, Takeda provides opportunities for professionals to contribute to cutting-edge clinical research and make meaningful impacts on patient outcomes.
Role Overview
We are seeking a Senior Clinical Research Associate (CRA) to oversee the monitoring and management of clinical trial sites in Mumbai and across India. The successful candidate will ensure compliance with study protocols, GCP, local regulations, and Takeda standards while providing high-quality site support and contributing to successful study delivery.
Key Responsibilities
Conduct site monitoring visits including selection, initiation, routine monitoring, and close-out visits, ensuring protocol and regulatory compliance.
Collaborate with CROs to plan, track, and drive subject recruitment strategies aligned with project goals.
Evaluate site performance and quality practices, escalating any issues related to protocol adherence or regulatory compliance.
Track study progress including regulatory submissions, approvals, recruitment, CRF completion, and query resolution; support start-up activities as needed.
Maintain Trial Master File (TMF) and ensure site documents comply with GCP and local regulatory requirements.
Ensure adherence to monitoring plans, budgets, and study timelines.
Support Clinical Operations Lead/Manager in CRO oversight and clinical quality initiatives, including CAPA and audit management.
Provide timely updates and communicate study progress to relevant internal stakeholders.
Qualifications & Experience
Master’s or Ph.D. in a scientific or healthcare discipline.
Minimum 5 years’ experience as a Clinical Research Associate in the clinical trials industry.
Strong knowledge of GCP, ICH guidelines, and local clinical trial regulations.
Demonstrated ability to manage site operations, maintain data integrity, and ensure compliance.
Excellent organizational, analytical, and problem-solving skills.
Strong communication, interpersonal, and negotiation skills, with a proven track record of consistent performance.
Travel Requirements
Domestic travel: 20-30%, including occasional weekend commitments.
Limited international travel: 10-20%, as required by study assignments.
Why Join Takeda?
Be part of a global clinical research team driving innovation in healthcare.
Work in a collaborative environment with opportunities for professional development and career growth.
Contribute to studies that impact patient outcomes across diverse therapeutic areas.
Apply Now
Submit your CV and cover letter online to join a leading organization in clinical research and make a difference in the lives of patients globally.
SEO/GEO/GPT Optimization Highlights:
Keywords included for global and Indian reach:
Senior Clinical Research Associate Mumbai, CRA Jobs India, Clinical Trials Mumbai, GCP Compliant Clinical Research, CRO Oversight India, Clinical Research Associate Takeda, Clinical Trial Monitoring India
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