• Document Controller and Training Coordinator

    Job Location UK-Nottingham
    Regular Full-Time
  • Overview

    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to or follow us on LinkedIn, Twitter, and Facebook.


    ERT's Training Coordinator focuses on the development, coordination, execution, and maintenance of internal training and the maintenance of training documentation records.




    1. Maintain the company’s departmental training programs and the company’s training documentation records through the administration of TMSWeb, in accordance with SOP 105.


    • Work with department managements to document and maintain current training programs for all department positions.
    • Ensure that all training records submitted are complete and accurate.
    • Administer the TMSWeb application to:

                   - Maintain an up-to-date user list.

                   - Make appropriate links to track employee required training.

                   - Send out appropriate training activities to employees according to their company                       position and associated CRD.

                   - Run reports to monitor employee training deficiencies.

                   - Enter training dates for instructor led type training, according to the processes                           outlined in SOP 105.

                   - Manage all employee CVs and Signature Logs according to SOP 105 and make                            them available upon request.

                   - Support triennial job description review process outline in SOP 2501.


    2. Maintain the company’s Controlled documents through the administration of TMSWeb, in accordance with SOP 107.

    • Ensure that all quality documents and operational documents designated as "controlled" are maintained in compliance with regulatory authorities and internal standards and can be efficiently retrieved in the event of an audit.
    • Implement procedures to ensure consistent maintenance of all controlled documents held in the TMS Web document management system
    • Maintain systems to accurately track and retrieve documents upon request.
    • Perform reviews of quality documents for completeness and accuracy.
    • Provide regular compliance and SOP status reports of central file contents through the use of document-tracking database.
    • Administer the TMSWeb application to:

                   - Run reports to monitor biennial review schedules

                   - Provide documentation of review according to processes outlined in SOP 917.

    • Coordinate the archiving of quality documents as required.
    • Provide appropriate TMS training for company personnel.
    • Develop and execute strategies to promote excellent customer service.



    1. Support the implementation of new/revised data systems, technologies, and methods to improve ERT services or support Operation expansion. This includes:

    • Participating in systems implementation teams.
    • Establishing User Requirements.
    • Conducting test scripts and ad hoc testing.
    • Creating system SOPs and developing manuals and training materials.
    • Completing all necessary training and competency testing.

    2. Provide support for the execution of the Employee Orientation program, working closely with the Human Resources Department.


    3. Assist departments, when requested and with the agreement of QA management, with training development and delivery.


    4. Assist departments, when requested with collection, organization and management of documentation to support the QA department.

    5. Manage and maintain the eHealth Education website.

    The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.




    1. Bachelor Degree required. Biology/science major preferred.  
    2. 2-3 years of eRT experience with at least 3 years of related business experience in training or at least 5 years experience in training software products and/or health sciences.
    3. Ability and desire to coach other staff members in instructional design & training skills.
    4. Knowledge of the pharmaceutical drug development process, ECG endpoints, and CPMP guidelines.
    5. General knowledge of Pharmaceutical Regulatory practices as they pertain to use of electronic data collection and results reporting.
    6. Trainers should demonstrate excellence in employee development and problem solving skills.
    7. Trainers should demonstrate excellence in communication and presentation skills with both trainee and management staff.
    8. Trainers involved in CSS Specialist training should demonstrate superior knowledge of cardiac endpoints and collection techniques.
    9. Trainers should be motivated to continue to expand their technical and scientific knowledge to elevate academic resources for trainees and ERT employees.

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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