Regional Site Start Up II - FSP

Job summary

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 t…

Job details

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 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

What you’ll do

Lead and deliver site start-up and activation activities for clinical trials to ensure timely activation and compliance. Manage essential documents, maintain site relationships, and collaborate cross-functionally to meet study milestone timelines.

Requirements

Requires a Bachelor's degree and 3-4 years of experience in clinical drug development, specifically working with US and Canada. Must be proficient in CTMS, TMF, and have a strong knowledge of ICH/GCP regulatory guidelines.

Listed skills

• Collections · Preferred
• Collaboration · Preferred
• Interpersonal · Preferred
• Attention to detail · Preferred
• Teams · Preferred
• Compliance · Preferred
• Clear Communication · Preferred
• management · Preferred
• Process · Preferred
• Communication · Preferred
• Development · Preferred
• Google Cloud · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Site Start Up
• Site Activation
• Clinical Trial Management
• Regulatory Compliance
• ICH-GCP
• Vendor Management
• CTMS
• TMF
• Interpersonal Skills
• Project Management
• Problem Solving
• Cross-Functional Collaboration