Takeda Hiring Clinical Research Associate
Company Overview:
Takeda Pharmaceutical Co., Ltd. is a global biopharmaceutical company with a 240-year history. Headquartered in Osaka, Japan, Takeda is committed to improving health through medical innovation.
Position Name:
Clinical Trial Associate
Organization:
Takeda
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience:
- 3 Years
Salary:
- ₹45,000 – ₹55,000 / month
Location:
- Gurgaon, Haryana
Job Description:
Objectives:
- Manage the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).
- Oversee the review, approval, and accuracy of eTMF documents.
- Generate reports to measure completeness, accuracy, and timeliness of the eTMF.
Accountabilities:
| Responsibilities | Details |
|---|---|
| Develop study-specific eTMF plans | Create plans tailored to individual clinical studies. |
| Perform quality control | Ensure documents meet eTMF specifications, ICH-GCP guidelines, regulatory requirements, and SOPs. |
| Address eTMF-related questions | Provide support and best practice recommendations for system users. |
| Maintain Essential Document Lists (EDLs) | Keep EDLs updated and monitor study-specific eTMF trends. |
| Assist with inspections and audits | Support inspection and audit-related activities. |
| Stay updated | Keep informed about the TMF Reference Model, industry best practices, and regulatory requirements. |
| Support Clinical Operations | Assist in overseeing CROs and collaborate with study teams to configure CTMS according to study requirements. |
| Lead meetings | Address trends, issues, and establish industry standards. |
| Improve CTMS functionality | Continuously assess and track issues for future enhancements or training needs. |
Education, Behavioral Competencies, and Skills:
- Minimum Bachelor’s degree in science/healthcare field.
- 3+ years of clinical research and TMF experience at a biotech, pharmaceutical company, or CRO.
- Experience with eTMF system software, preferably Veeva Vault CTMS & eTMF.
- Good knowledge of GCP and local clinical trial regulations.
- Strong organizational and problem-solving skills.
- Superior communication, strategic, interpersonal, and negotiating skills.
- Proven stable performance over the past 2-3 years.
Travel Requirements:
- Domestic travel: 20-30%, including some weekends.
- International travel: 10-20%.
Employment Type:
- Full-time, Regular Employee
Location:
- Gurgaon, Haryana, India
Application Process:
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