Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are searching for a Central Files Controller to join our team!
This position can be located remotely anywhere globally. Depending on the experience of the candidate it can be filled at a Grade 28 or Grade 29 level.
The Central Files Controller will provide a wide range of support functions for the company's electronic document management system, Enterprise Library Vaulting and Information System (ELVIS). Act as the first line of support for technical and non-technical issues among the project team members. Work directly with the project team members to ensure that projects are properly set up, maintained, and archived, and that users are properly trained to use Central Files.
Support Central Files Controllers and other ELVIS staff in the management of the ELVIS Central Files process across all functions and provide system support for all end users.
Serve as a team member for application enhancements or special projects, upon request.
As agreed with Central Files Manager, organize the agenda and lead the weekly/monthly Central Files Controllers' teleconferences.
Support projects globally or within a specific therapeutic project unit, country, region or client, as assigned.
Set up, maintain, and provide technical support for clinical systems for assigned projects utilizing ELVIS Central Files.
Review CSV documentation and Project Specific Guidelines as needed (or per SOPs).
Ensure the consistent use of clinical systems and/or procedures for assigned projects; conduct QC checks within a project, run metrics reports as necessary and provide feedback as appropriate to PMs/CTLs.
Monitor system usage against established guidelines. Work with regional end-users or project team members to correct compliance issues in a timely manner.
Provide training on designated clinical systems to local and regional user(s) or project team(s).
Provide support to a designated region (multiple offices) or local office for designated clinical systems.
Participate in the development of system specifications and documentation, as well as, user testing of new enhancements/functionality and/or review of associated procedures, training, and documentation.
Review and execute test cases; sign off and document test cases.
Identify and record quality problems; suggest, initiate, recommend or provide solutions as appropriate.
Maintain awareness of overall developments in the field of clinical research.
Understand financial and performance metrics requirements within region and/or project.
Participate in required communication pathways.
Receive the specific training for the position in order to update their knowledge.
Adhere to all relevant associated SOPs/Work Instructions and other guidelines.
Provide back-up assistance to other Central Files Controllers as needed.
Utilize system technical expertise to produce ad-hoc queries and metric reports providing information essential to business requirements.
Provide training, coaching and support to local Central Files Controllers and Champions, including communication of new procedures, systems changes etc.
Serve as a mentor to newer Central Files staff, as applicable.
As agreed with ELVIS Manager, update training material with new procedures, system changes, etc.; update standard system forms and assist with the coordination and implementation of training as needed.
Bachelors degree in Information Management, Health, or Science with 3 years experience in a clinical research environment preferred; or equivalent combination of education, training and experience.
Basic knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines.
Basic knowledge of how trial master files (TMF) are managed and maintained, and what essential documents constitute a TMF.
Basic understanding of common electronic document management principles such as taxonomy, nested objects, inheritance and metadata.
Knowledge and ability to work cross-functionally and an understanding of Quintiles project team structure.
Computer literacy required, including well-developed computer skills in MS Word and Excel.
Effective problem-solving skills.
Effective communication and interpersonal skills.
Effective organizational skills and attention to detail.
Ability to run ad hoc queries and reports for a given project.
Ability to work independently on assigned projects with minimal supervision.
Ability to handle multiple priorities and meet deadlines.
Ability to independently conduct designated clinical system and/or process training, as well as, customer demonstrations/presentations, as needed.
Ability to establish and maintain effective working relationships with co-workers and managers.
Quintiles Transnational - 24 months ago
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