Regional Site Start Up II - FSP

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 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.

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