500 River Ridge Drive Second Floor
Job Category: Clinical: Clinical Operations and Development
Job Number: 2195
The Clinical Systems Administrator (a newly created position based on growth) will play a leading role in the evaluation, implementation, management and support of the Clinical Systems used by our Client’ s Clinical Operations team. This role will work closely with Project Managers (PM), and the Head of Clinical Operations (CO) to gather requirements and report status. Familiarity with clinical (trial) operations is key. This role will be the primary liaison with Information Technology (IT) and Quality Assurance (QA) during system evaluation and deployment, and to help ensure projects are in-line with existing company systems, standards and policies.
- Works with teams to assist in identifying potential vendors to support clinical activity:
- In general, will serve as a clinical systems subject matter expert during the vendor/system selection process;
- Will be responsible for working with the team to develop vendor/system evaluation criteria;
- Depending upon the vendor type, may participate and/or coordinate in system demonstrations;
- Will assist the team in the review of vendor capabilities and determination of fit with current and future Company needs;
- Will provide recommendations to Project Managers (PM), and Head of Clinical Operations (CO) or designee.
- Works with PMs, and Quality Assurance (QA) to ensure each system is appropriately qualified the system for use:
- May participate in the review and finalization of the system validation plan as necessary and may delegate to other system technical experts;
- During qualification process may act as a system functional expert or delegate to other system technical experts to support qualification activity;
- Will provide input into issue remediation plans during system qualification, as appropriate.
System Build, Use, and Maintenance:
- Ensure that hardware and software are designed and installed in a manner that meets the needs of the organization in cooperation with the IT Department.
- During system build will provide input into system specifications and integrations based on project and company needs; in cooperation with the IT Department as required.
- Will provide input into identification of user types, system configuration, and identification of system support needs;
- Will identify procedural or Standard Operating Procedure (SOP) gaps, and may author or review, as appropriate;
- Will perform a review of UAT plans and test scripts prior to performance of UAT.
- May participate in system UAT testing prior to system go-live; at minimum will ensure system owners have completed UAT prior to system go-live, if applicable.
- Will manage system user accounts, credentials, access control and monitoring and trials:
- Will work with PM, and CO (or other department system owners) to determine which studies or activities will be implemented in each system;
- Will work with PM and vendor to manage the user access aspects of the implementation;
- Will maintain a list of approved system users along with their authentication and authorization levels and role assignment.
- Access permissions will be assigned by the PM/CO/line manager (as appropriate).
- This role will provide a process for setting these access permissions as well as implementing them;
- Will work with the PM, and CO (or other department system owners) during development of timelines for system build, UAT and implementation based on program needs;
- Will work with the CO or designee (or other department system owners) and QA to develop a comprehensive plan including timelines for system maintenance, planned updates, or re-validation, as appropriate;
- Will monitor systems performance and provide recommendations to system owners, as appropriate;
- Will provide recommendations regarding system installations, maintenance and upgrades;
- Will ensure systems maintain a validated status through Change Control:
- Will act as a functional expert during the preparation or conduct of a change assessment;
- Will perform a functional assessment of the proposed change with a particular focus on potential impact to ongoing projects/studies and will provide an assessment of risk/impact to, PM and/or CO, as appropriate;
- Will research updates to systems and functionality and provide recommendations that can improve company capacity and productivity.
- Will work with appropriate team members regarding functional aspects for system close-out or shut down.
- Information Technology Support Activities:
- Where necessary this role may act as a primary liaison for other IT functions and activities including
- Will ensure clinical operations IT related activities are conducted in compliance with current Data Privacy standards and other applicable regulations.
- Bachelor’ s Degree is required, computer science or other technical degree is a plus
- Minimum 2 years prior experience in biotechnology or pharmaceuticals industry
- Minimum 5 years related work experience
- Prior experience with electronic data capture systems
- Knowledge of 21 CFR Part 11, EU Directive 95/46/EC, and other applicable regulations
- Knowledge of regulations related to electronic data capture, patient privacy, and other applicable issues which may impact on system implementation, or use.
- Extensive knowledge of departmental processes
- Knowledge base of devices, software and security with respect to clinical trial systems operations or other IT systems
- Effective communication skills