Centralized Study Specialist I (eTMF)

for 4 year(s) of experience
₹ Not Disclosed by Recruiter

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Posted: 270 days agoJob Applicants: 151Job Views: 25

Job Description

Job Overview:


  • Perform eTMF periodic Review of documents for Content & Completeness check
  • Perform eTMF Reconciliation tasks (Missing document, duplicates identification etc)
  • Follow with action owners for Open TMF Issues
  • Maintain the eTMF in state of Inspection Readiness
  • Ensure eTMF is always audit ready
  • Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends
  • Compliance to TMF Completeness, TMF Reviews & TMF Issue Resolutions
  • Commitment to continuous improvement of TMF delivery
  • Driving a culture of Inspection Readiness
  • Creating a seamless TMF delivery process

Education/Qualifications:


  • Associates - 4 Years with Degree in Life science
  • 4+years with relevant skill - eTMF periodic review or Monitoring skills

Experience:


  • Minimum 4 years' experience working in a clinical research environment.
  • Understanding of GCP and ICH guidelines.
  • Knowledge of Regulatory/Clinical document requirements.
  • Extensive experience working in clinical electronic systems.
  • Extensive knowledge of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
  • Excellent interpersonal skills.

Role:Clinical research Scientist

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional AreaResearch & Development

Role CategoryPharmaceutical & Biotechnology

Employment Type:Full Time, Permanent

Education

UG:B.Tech/B.E. in Bio-Chemistry/Bio-Technology,B.Sc in Bio-Chemistry,B.Pharma in Pharmacy

Company Profile

Covance

Covance, a business segment of Labcorp, is recognized as a leader in drug development, medical device, diagnostics, crop protection and chemical testing because of our exceptional people. We embrace and celebrate the different strengths, experiences and perspectives of our nearly 70,000 enterprise team members across the globe. Our team is driven by our mission to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you will have the opportunity to explore diverse projects and unique career paths across life science. Join us and discover your extraordinary potential.
Company Info
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Contact Company:Covance

Address:Vaishnavi MSR, No. 29,,11th Floor, Union Street, Off Cubbon Road, Bangalore, BANGALORE, Karnataka, India