Clinical Trial Associate Opportunity at Takeda’s Global
Position Name:
Clinical Trial Associate
Organization:
Takeda’s Global
Qualification:
B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Location:
Gurgaon, Haryana
Salary:
Not disclosed
Table of Contents
About Takeda’s Global
Takeda Pharmaceutical Company is a values-driven, R&D-focused global biopharmaceutical leader dedicated to improving health and delivering life-saving innovations worldwide. With a rich history, Takeda focuses on creating medications that transform patients’ lives and contribute to a sustainable healthcare system.
This is an exciting opportunity to join Takeda’s Global Portfolio Division, where you will contribute to state-of-the-art clinical research and development. If you are passionate about clinical trials, regulatory compliance, and advancing healthcare, this role is for you.
Job Responsibilities
As a Clinical Trial Associate at Takeda, you will be responsible for managing the Electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS). Your daily tasks will include:
- Overseeing eTMF Plans: Creating and customizing eTMF plans for each study.
- Document Quality Checks: Reviewing submitted documents in the eTMF to ensure quality and regulatory compliance.
- Regulatory Compliance: Ensuring documentation aligns with ICH-GCP guidelines, regulatory requirements, and eTMF specifications.
- Tracking eTMF Trends: Monitoring and identifying patterns in eTMF specific to each study.
- Audit & Inspection Support: Assisting in tasks related to audits and inspections.
- CRO Oversight Support: Helping clinical operations managers or leads in CRO oversight activities.
- CTMS Management: Collaborating with research teams to set up programs, sites, and studies in CTMS.
- Organizing Meetings: Coordinating meetings to set standards, address issues, and ensure CTMS functionality.
Key Responsibilities
| Task | Description |
|---|---|
| eTMF Plan Management | Develop and oversee eTMF plans specific to each study. |
| Document Quality Control | Ensure submitted eTMF documents are complete and compliant. |
| Regulatory Compliance | Ensure adherence to ICH-GCP, local clinical trial regulations. |
| eTMF Trend Monitoring | Track and respond to eTMF system queries and patterns. |
| Audit/Inspection Assistance | Support audit and inspection activities. |
| CRO Oversight | Assist in clinical operations and CRO management. |
| CTMS Support | Collaborate with teams on CTMS setup and management. |
| Meeting Coordination | Lead meetings to resolve CTMS issues and ensure smooth operations. |
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Qualifications and Skills
To be successful in this role, you should have the following qualifications and skills:
Education:
- Minimum: Bachelor’s degree in science, Life Sciences, or a related healthcare field such as Pharmacy.
Experience:
- At least 3 years of relevant experience in clinical research and Trial Master File (TMF), preferably within the pharmaceutical, biotechnology, or CRO sectors.
- Experience working with Veeva Vault or similar eTMF system software is highly desirable.
Skills:
- Knowledge of Clinical Trial Regulations: Comprehensive understanding of GCP guidelines and local clinical trial regulations.
- Problem-Solving & Communication: Strong analytical, organizational, and communication skills.
- Technical Proficiency: Experience with eTMF and CTMS systems, particularly Veeva Vault.
How to Apply
To apply for this exciting opportunity as a Clinical Trial Associate at Takeda in Gurgaon, Haryana, follow these steps:
- Visit the Takeda Careers Portal.
- Search for Job ID R0120735 under the Research & Development section.
- Click the “Apply” button to start your application.
- Ensure that all your information is accurate and up to date.
Application Link: Takeda Careers Portal
Why Join Takeda?
- Global Leader: Takeda is a pioneer in the global pharmaceutical industry, known for its commitment to innovation and patient-centric care.
- Cutting-Edge Research: You’ll have the opportunity to contribute to groundbreaking clinical research.
- Career Development: Takeda offers excellent career development opportunities in an international and collaborative environment.
If you’re passionate about advancing clinical research and want to be part of a company that makes a global impact, apply today and help shape the future of healthcare!
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