Regional Site Start Up II - FSP

About the role

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP is looking for Regional Site Start Up II to join our team in 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 efficiently achieve 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 share, as appropriate, all 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 (ICF) 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 Provide regional expertise, addressing specific geographic challenges to facilitate site activation.

Serve as the primary point of contact and escalation point for sites: troubleshoot issues and provide strategic solutions to ensure activation timelines are achieved Update trackers with key study information, risks and mitigation strategies Ensure all site start-up documents are filed in the TMF and are inspection ready Support inspection readiness activities related 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 all global and local regulatory requirements Process Optimization and Compliance: Maintain accurate records of site activation progress, 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