Veeva Vault eTMF officer/ Pan India
- Golden Opportunities
- 2 - 10 Years
- Chennai
- 4 years ago
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Job Description
Job Description :Skills:
- Bachelors degree in related area; and/or equivalent experience/training.
- Experience in eTMF System development and configuration in Veeva Vault experience required including experience in study start-up system setup maintenance and closeout activities.
- Subject matter expertise with the TMF Reference Model clinical trial activities and related terminology.
- Demonstrated experience with CTMS EDC and eTMF technologies.
- Extensive knowledge and application of ALCOA FDA standards Good Clinical Practice and Good Documentation Practice per ICH (E6 (R2).
- Support the definition of system user requirements and the team across other workstreams (e.g. system design and configuration customization data migration and systems integration) for Veeva Vault eTMF application.
- Should have experience in EDL (Expected Document List) management Configuration of new sites user access provisioning UAT testing etc.
- Direct system implementation experience either as a consultant business or IT representative for at least one of the following systems: eTMF CTMS Study Startup or eRegulatory/ISF.
- Enable new processes system deployment and continuous improvements by defining a roll-out strategy and post-live governance
- Should have experience in User Access Management platform support triaging incidents root cause analyzing problem tickets assessing & estimating requests for change tracking escalations and working with vendors to resolve system issues.
- Demonstrated understanding of the clinical study phases involved in Drug Development and the corresponding records requirements in accordance to federal regulations.
- Thorough knowledge and ability to apply all relevant regulatory guidelines regulations policies and federal guidance documents.
- Highly proficient in CTMS and eTMF technologies. Experience and skills in navigating eTMFs preferred.
- Should have experience in eTMF system migration & incident management Process Management Service task Management at L1/L2/L3 Levels for Veeva applications.
- Demonstrated experience in developing the study specific environment creating sites/ milestones/artifacts/metadata fields/reports/workflows/lifecycles etc. in production area.
- Able to conduct trainings on eTMF system maintenance and configuration for the study team members.
- Maintain the TMF in a state of audit readiness for quality and compliance.
- Should be able to help support the records archival team & Project Managers on study closure and transferring the data back to client.
- Experience in middleware based Veeva Vault integrations and Veeva Vault related migrations .
- Good to have Vault SDK development experience
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: PharmaceuticalRole Category: Other PharmaRole/Responsibilies: Veeva Vault eTMF officer/ Pan IndiaContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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