Takeda Hiring Clinical Research Associate

Takeda Hiring Clinical Research Associate
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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:

ResponsibilitiesDetails
Develop study-specific eTMF plansCreate plans tailored to individual clinical studies.
Perform quality controlEnsure documents meet eTMF specifications, ICH-GCP guidelines, regulatory requirements, and SOPs.
Address eTMF-related questionsProvide 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 auditsSupport inspection and audit-related activities.
Stay updatedKeep informed about the TMF Reference Model, industry best practices, and regulatory requirements.
Support Clinical OperationsAssist in overseeing CROs and collaborate with study teams to configure CTMS according to study requirements.
Lead meetingsAddress trends, issues, and establish industry standards.
Improve CTMS functionalityContinuously 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.
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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:
By clicking the “Apply” button, you acknowledge that the employment application process with Takeda will commence. The information you provide in your application will be processed in line with Takeda’s Privacy Notice and Terms of Use. All information submitted in your application must be true to the best of your knowledge.


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