Job Description

CTMS and eTMF Systems Administrator  

Location:

Philadelphia,  Massachusetts

Date Posted:

6/26/2023

Employment Type:

Permanent

Recruiter:

Mohamed Barami

Recruiter Email:

mo.barami@avidtr.com

Job ID:

JN -062023-15630

Job Description

CTMS and eTMF Systems Administrator  

Working under the direction of the IT Director, the CTMS and eTMF Systems Administrator will be responsible for the operational management and administration of the CTMS and eTMF systems. Working closely with the Clinical Operations team, the CTMS and eTMF Systems Administrator will define and manage clinical trials in these applications.  Duties include providing internal IT support, managing web-based services and internal customer support for the Coalition and its affiliated entities.

Job Requirements

Skills/Abilities
The CTMS and eTMF Systems Administrator’s role requires the following:
  • Extensive knowledge of Clinical Trial Management (CTMS) systems.
  • Extensive knowledge of document management systems (document lifecycles, workflows, user access and permissions).
  • Management of the eTMF file plan, aligning it with individual study specifications.
  • Exemplary interpersonal, communication and education skills toward facilitating the use of new software systems.
  • This role necessitates self-direction, motivation, organization, strict attention to detail and problem solving and decision-making abilities.

Experience
  • A minimum of three (3) years of CTMS and TMF management experience.
  • Advanced working knowledge of DIA Reference Model TMF structure (preferably version 3.0).
  • Experience working in a CRO or Pharmaceutical Clinical Trial environment.
  • Experience working in the field of computer systems programming; operations; systems, data base or network enterprise system support (hardware or software level); or information technology management consulting.
  • Systems analysis experience a plus
  • Able to facilitate internal end-user proficiency.
  • Able to design and maintain efficient customer portal support and feedback channels.
  • Advanced knowledge of data security and encryption.
  • Able to keep up with IT advancements.
  • Knowledge of relevant licensing and industry compliance regulations.

Education
  • A Bachelor’s Degree with a major in computer science, or management information systems and/or relevant professional experience is required. 
  • An accreditation in management consultancy

Responsibilities 
  • Manage the implementation and maintenance of the Medidata CTMS and eTMF systems
  • Analyze and revise existing SOPs related to CTMS/ eTMF systems.
  • Develop and maintain work practice documents for eTMF and CTMS systems.
  • Provide internal training for CTMS and eTMF systems, work practices, etc.
  • Serve as a resource for personnel questions related to CTMS and eTMF systems.
  • Collaborate with the vendor on on-going system issues, upgrades, and maintenance.
  • Set up new studies in eTMF and CTMS systems.
  • New user account administration
  • Manage external user access
  • Acts as the liaison with collaborators and vendors, internal departments, and clinical sites to ensure system viability and user familiarity and proficiency.
  • Works with staff to develop and deliver all appropriate and necessary reports.
  • Works with key departments to ensure and maintain relevant efficiencies within the system. 
  • Assists management with identifying areas of improvement and enhancements and obtains approval for system development projects.
  • Efficiently integrates new systems, programs, and applications with business operations and services.
  • Analyzes and improves the performance of web-based customer portals and support services.
  • Monitors product licenses and ensures compliance with IT industry regulations.
  • Ensures that computer hardware remains compatible with system enhancements and updates.
  • Participates in on-going continuing education courses or seminars.
 
 
Apply for this job