Regional Site Start Up II - FSP

Parexel; Oregon; Hybrid; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Parexel is seeking a Regional Site Start Up II to lead site activation across clinical trials in the US and Canada. You will coordinate cross-functional teams, gather regulatory documents, and ensure timely activation while maintaining regulatory compliance and strong site relationships.

Ideal candidates bring 3–4 years of US/Canada experience, proficiency with CTMS/TMF, and a data-driven, proactive mindset to optimize start-up processes and timelines.

Qualifikationen

• Bachelor's degree required (minimum)
• 3–4 years of experience in US/Canada
• Experience with site start-up and activation in clinical trials
• Knowledge of ICH-GCP and regulatory guidelines
• Proven ability to manage multiple sites and timelines
• Strong communication and leadership abilities

Aufgaben

• Lead and deliver site activation timelines for assigned sites
• Gather, organize and share essential documents for regulatory submissions
• Maintain site information in CTMS and ensure TMF readiness
• Ensure regulatory packages meet country requirements and ICH-GCP compliance
• Review Informed Consent Forms as requested
• Translate essential documents for regulatory submissions as needed
• Provide regional expertise to address geographic challenges and act as primary contact for sites
• Update trackers with study information, risks, and mitigations
• Support inspection readiness related to site start-up documents
• Collaborate with internal and external stakeholders to ensure alignment and timely execution

Kenntnisse

Interpersonal leadership

Data-driven planning

Communication

Time management

Vendor management

CTMS proficiency

TMF knowledge

Regulatory knowledge

Team collaboration

Problem solving

Ausbildung

Bachelor's Degree

Tools

CTMS

TMF

MS Office

PowerPoint

Word

Excel

Jobbeschreibung

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 elevate 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 via 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, Excel
• 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 open 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

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.