eTMF Operation Analyst

Bristol Myers Squibb

10 - 15 years

3 - 7 Lacs

hyderabad

Posted:4 hours ago| Platform:

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Skills Required

clinical operations ich-gcp guidelines etmf documentation clinical data management veeva excel salesforce records management operations clinical research strong communication skills writing ich-gcp ctms clinical trials vault communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2))
Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review.
Experience managing clinical content in a records management system or electronic Trial Master File system.
Have strong communication skills, verbal and written.

Experience Requirements:

At least 3-5 years of eTMF, preferrable using Veeva Vault eTMF, and clinical trial experience.
Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment

Degree Requirements :

Minimum of bachelor s degree in a scientific or related discipline

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