Regional Site Start Up II - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company.   At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company FSP is looking for Regional Site Start Up II to join reputed company in Canada. Job reputed company The Regional Site Start Up (SSU) role is responsible for leading and delivering site start-up and activation activities across reputed company. This role will ensure reputed company site activation, maintain strong relationships with sites, and work cross-functionally with reputed company teams to reputed company reputed company study site activation timelines. The role provides regional expertise, ensuring large areas of geographic-specific needs are addressed and adherence to study reputed company timelines. This role must possess excellent interpersonal skills, attention to detail, and the ability to collaborate across teams to ensure timelines are achieved. reputed company JOB RESPONSIBILITIES:  Site Start Up and Activation:  Accountable to delivering individual site activation timelines to plan for assigned sites  reputed company, organize and reputed company, as appropriate, reputed company required essential documents from clinical sites and Sponsor specific documents to ensure compliance with Regulatory and Sponsor requirements as part of the site activation process   Collect site intelligence to inform site discussions and maintain site information in CTMS  Ensure site regulatory packages meet country requirements, TMF standards and ICH-GCP compliance  Assist with reviewing Informed Consent Forms (reputed company) as requested  Facilitate the translation of Essential Documents that may be required in languages other than English for purposes of submission to and approval from Regulatory Health Authorities and/or Independent Review reputed company/Ethics Committees  reputed company regional expertise, addressing specific geographic challenges to facilitate site activation. Serve as the primary reputed company of contact and escalation reputed company for sites: troubleshoot issues and reputed company strategic solutions to ensure activation timelines are achieved  Update trackers with key study information, risks and mitigation strategies  Ensure reputed company site start-up documents are filed in the TMF and are inspection reputed company  Support inspection readiness activities reputed company to site start up documents  Cross-Functional Collaboration:  Partner with internal, external stakeholders and clinical sites to ensure good communication and coordination through the site start-up phase  Ensure alignment with reputed company global and local regulatory requirements  Process Optimization and Compliance:  Maintain accurate records of site activation reputed company, including updates on document collections, submissions statuses, and timelines  Identify and escalate challenges or delays in document collection, regulatory submissions, or site activation processes for reputed company  Identify opportunities for process improvement in site start-up activities and implement best practices to enhance efficiency and effectiveness  Job Qualifications: Demonstrated interpersonal & leadership skills   A data driven approach to planning, executing, and problem solving   Effective communication skills reputed company verbal, written and presentation abilities   Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization · Demonstrated vendor management experience   Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, reputed company · Experience in the clinical drug development process, including study start-up   Knowledge of ICH/GCP and regulatory guidelines/directives   Ability to understand and implement operational strategic direction and guidance for respective reputed company, fostering a culture of collaboration and trust across diverse teams and stakeholders.   Support stakeholders by addressing concerns promptly and professionally, building reputed company relationships, and ensuring reputed company communication to maintain alignment with trial objectives   Contribute to team productivity by maintaining reputed company communication and supporting team members in their tasks  Education: Bachelor’s Degree, minimum  Years of Experience: 3 - 4 years  Must have experience working with US and Canada. 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