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About Company

Takeda Pharmaceutical Co., Ltd. is a global biopharmaceutical company that researches, develops, manufactures, imports, exports, and markets pharmaceutical drugs. Founded in 1781 by Takeda Chobei and headquartered in Osaka, Japan, Takeda has a 240-year history and Japanese heritage. The company's mission is to improve health and create a brighter future for people worldwide through medical innovation

Position Name :

Clinical Trial Associate

Organization :



B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences


3 Years


45,000 - 55,000 /month


Gurgaon, Haryana

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Job Description


  • 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.


  • Develop study-specific eTMF plans for clinical studies.
  • Perform quality control of documents in the eTMF.
  • Ensure documentation complies with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and SOPs.
  • Address eTMF-related questions and provide system user support.
  • Remediate documents that fail quality control and provide best practice recommendations.
  • Maintain Essential Document Lists (EDLs) continuously.
  • Monitor study-specific eTMF trends and communicate with Clinical Operations or other functional teams.
  • Assist with inspection and audit-related activities.
  • Stay updated on the TMF Reference Model, industry best practices, and regulatory requirements.
  • Support Clinical Operations Lead/Manager in overseeing CROs.
  • Collaborate with study teams to configure CTMS according to study requirements.
  • Manage end-user and group permissions settings.
  • Lead meetings to address trends, issues, and establish industry standards.
  • Continuously assess and improve CTMS functionality; 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%.

Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full-time

Locations: Gurgaon, Haryana, India

Application Link

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