Job Description
Takeda Pharmaceutical Company Limited, a global leader in research and development-driven healthcare, is seeking a highly skilled Senior Clinical Research Associate to join our dynamic team. With a commitment to improving the quality of life for patients worldwide, Takeda focuses on core therapeutic areas including oncology, gastroenterology, neuroscience, and vaccines.
Key Details
- Position: Senior Clinical Research Associate
- Location: Mumbai, Maharashtra
- Industry Type: Pharma/ Healthcare/ Clinical research
- Functional Area: Research & Development
- End Date: April 30, 2024
Responsibilities
- Conduct monitoring and site management activities to ensure compliance with study protocol, regulations, and Takeda requirements
- Perform site monitoring visits (selection, initiation, monitoring, and close-out)
- Collaborate with CROs to drive subject recruitment plans and enhance predictability
- Evaluate site practices for protocol adherence and regulatory compliance
- Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Maintain Trial Master File (TMF) and ensure document compliance
- Support clinical quality management and oversight activities
- Monitor study budget adherence and communicate study updates to stakeholders
Candidate Profile
- Master’s or Ph.D. degree in scientific discipline or healthcare
- 5 years experience in the clinical trials industry as a Clinical Research Associate
- Strong knowledge of GCP and local clinical trial regulations
- Organizational and problem-solving skills
- Excellent communication, strategic, interpersonal, and negotiating skills
- Proven performance records over the past 2-3 years
Travel Requirements
- Domestic travel required (20-30%), including some weekend commitments
- Limited international travel (10-20%) may be required
Don’t miss this opportunity to be part of Takeda’s mission to transform scientific innovation into life-changing medicines. Apply now and contribute to making a difference in patients’ lives worldwide!