Regulatory Start-Up Manager II - Italy
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Regulatory Start-Up Manager II (RSM II) to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
The Regulatory Start-Up Manager II (RSM II) is responsible for the coordination and strategic planning of all country Competent Authority (CA), central/local Ethics Committee submission (LEC/CEC) as well as any additional board/evaluating body required to obtain study approval that allow the conduct of clinical research within the countries required. The RSM directs, supervises and supports all Study Start up (SSU) staff on the project team; liaises with the client and collaborates with project team members in other functional areas to ensure delivery within contractual obligations. The RSM is accountable for delivery of startup activities at the project level. The RSM will successfully meet contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The RSM maintains a proactive, positive, results-oriented work environment.
Your main responsibilities:
- 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.).
- 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
- 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.
- Education to university degree level (pharmacy, medicine or related natural sciences is a plus)
- Min. 7 years professional experience, including at least 4 years of previous experience as Regulatory Start-up Manager at a local/country level, for newly awarded studies containing countries from the same region, and may take a multi-region study in Start-up under supervision, or maintenance studies
- At least 2 years of hands-on experience in global studies·
- Experience working on ample number of countries in global studies
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155regulations, drug / device development, and start-up procedures
- Knowledge of ICH / GCP regulations / country specific regulations as applicable
- Ability to work accurately and to interpret the relevant directives and guidelines
- Fluent verbal and written English
- Ability to fulfill objectives such as identification with the interests of sponsors, special focus on the wishes of the sponsors, completion of projects within the agreed budget and timelines
- Excellent team player, collaborative and able to build an effective team
- Ability to multitask and work effectively in a fast-paced environment with - - Strong verbal and written communication and negotiation skills
- Excellent organizational and time-management skills, able prioritize work to meet deadlines
- Accountable, dependable and strong commitment