Clinical eTMF System Administrator - Temp

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Location

Ardsley, NY

Summary

This position is responsible for providing system administration of Vault eTMF and operational support for all clinical study-related documentation, including establishing standard and best practices for the day-to-day operations related to the management of documents within Vault eTMF.  The Clinical Document Management eTMF System Administrator supports the management of Trial Master Files (TMF) for clinical trials.

Full Description

This position is responsible for providing system administration of Vault eTMF and operational support for all clinical study-related documentation, including establishing standard and best practices for the day-to-day operations related to the management of documents within Vault eTMF.  The Clinical Document Management eTMF System Administrator supports the management of Trial Master Files (TMF) for clinical trials.   

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Performs Day-to-Day management of documents and users within Vault eTMF.
  • Performs Instructor-Led Trainings on Vault eTMF to internal and external trainees with varying permission sets, including.
  • Manages periodic and ad-hoc system updates which includes working with IT and QA representatives to determine validation and testing requirements and open/close change controls around enabling new features or configuring system for use. Will be responsible for drafting validation documentation.
  • Maps and uploads documents from legacy TMF structures to current TMF structure and populates required metadata for archive into eTMF. This may include working with study team representatives to verify documentation is as expected within the system.
  • Assists with the preparation of the eTMF for internal audits, supports the resolution with identifying and implementing corrective actions to findings in audit reports.

Education or Experience:

  • Associate’s degree in computer information systems or a scientific or health-related field is preferred.
  • Minimum of 1-3 years of experience in computer information systems or clinical research required
  • Document Management experience preferred
  • Minimum of 1-2 years of experience assisting in the support or management of clinical trials at a pharmaceutical/ biotech company or CRO is preferred
  • Understanding of GCPs, FDA regulations and ICH guidelines is required
  • Familiarity with DIA TMF Reference Model is required
  • Experience with eTMF required, experience with Vault eTMF preferred.
  • Experience with various documentation management systems (e.g. Clinical Trial Management Systems [CTMS], DocCompliance etc.) preferred.

Computer Skills:         

  • Must be proficient in MS Office Suite and familiar with Adobe Acrobat

Other Skills and Abilities:       

  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects and timelines simultaneously.
  • Excellent organizational skills and attention to detail are required.
  • Strong proofreading, editing and reviewing skills are needed
  • Must be able to work independently, participate in meetings and possess problem solving skills.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • This position requires minimal travel, average travel for this position is 5-10% with some variation based on the demands of the business initiatives. Travel is for conferences, facility/site visits and to CROs.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands. 

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.