Regulatory Start Up Manager
- Experience Level
- Experienced (non-manager)
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We are actively recruiting for a Regulatory Start Up Manager to join our team. We can consider hiring in Ukraine, Spain, Romania, Bulgaria or other locations in Europe where we have an office presence.
The role of the RSM includes:
- Responsible for developing the Regulatory & start-up submission project plan. Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
- Responsible for the pertinent notifications throughout the trial (e.g. First patient-in, End of Trial)
- Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
- Responsible for identifying & communicating country timelines to our clients and project teams
- Responsible for identifying & communicating risks and contingency plans related to start up activities to our clients and project teams
- Oversees the site contract execution process in the studies that a Contracts Lead is not assigned
- Obtains the EudraCT number where delegated by Sponsor
- Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
- Review master IP labels and provides feedback on its potential acceptability to regulatory authorities including issues related to country adaptation
- Oversees the regulatory approval of IP release
- Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
For Start-up and Regulatory success:
- Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
- Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
- Produces and/or reviews submission components like the Patient Information Form/ICF.
- To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
- May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
- Must have direct access to the study budget and must communicate pertinent information related of such budget to the Start-Up staff so that they understand contractual expectations. If there is a significant deviation between the tasks and the contracted budget, the RL must discuss the situation with the PM until confident the discrepancy will be resolved.
- Attends Kick-Off Meeting, when required
For commercial success:
- At all times to maintain good, friendly and professional relationships with past, current and potential sponsors, and others with whom the company works
- Participates in corporate initiatives and actions that ensure the continued success of the company
- Keeps abreast of scientific developments and maintain technical expertise by attending courses, meetings, reading the literature and following announcements on the relevant websites
- Works with the PM to understand financial aspects of the project; cascades to all start-up team members the number of hours/tasks available per contract; monitors project performance
- Uses professionally recognized tools for planning and management of scope, timeline, resources, and budget. Ensures that minimum hours are used for tasks and that the Project Manager (PM) is pursuing out-of-scope work via the Change Order or financial reconciliation processes.
- Other activities as designated