Regional Site Start Up II - FSP

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials 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. Each 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 US or Canada. Job Summary The Regional Site Start Up (SSU) role is responsible for leading and delivering site start-up and activation activities across clinical trials. This role will ensure timely site activation, maintain strong relationships with sites, and work cross-functionally with internal and external 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 milestone timelines. This role must possess excellent interpersonal skills, attention to detail, and the ability to collaborate across teams to ensure timelines are achieved. CORE JOB RESPONSIBILITIES: Site Start Up and Activation: Accountable to delivering individual site activation timelines to plan for assigned sites Gather, 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 Board/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 resolution 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 clinical trials, fostering a culture of collaboration and trust across diverse teams and stakeholders. Support stakeholders by addressing concerns promptly and professionally, building positive relationships, and ensuring clear 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. EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply To This Job