Parexel
Regional Site Start Up II - FSP
Canada-Ontario-Remote · Mid
Sponsorship not specifiedDetected 8 days ago
GCPExcelProcess ImprovementVendor ManagementClinical TrialsLeadershipCommunicationCollaborationProblem SolvingMicrosoft Office
About the role
- The Regional Site Start Up (SSU) role is responsible for leading and delivering site start-up and activation activities across clinical trials.
- The role provides regional expertise, ensuring large areas of geographic-specific needs are addressed and adherence to study milestone timelines.
- Accountable to delivering individual site activation timelines to plan for assigned sites
Responsibilities
- Collect site intelligence to inform site discussions and maintain site information in CTMS
- 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
- Partner with internal, external stakeholders and clinical sites to ensure good communication and coordination through the site start-up phase
- 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.
- This role must possess excellent interpersonal skills, attention to detail, and the ability to collaborate across teams to ensure timelines are achieved.
Requirements
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization · Demonstrated vendor management experience
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Years of Experience: 3.
- Must have experience working with US and Canada.
- Bachelor's Degree, minimum
- A data driven approach to planning, executing, and problem solving
- 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
- 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
Skills
- Demonstrated interpersonal & leadership skills
- Effective communication skills via verbal, written and presentation abilities
Benefits
- At Parexel, we all share the same goal - to improve the world's health.
- Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
Company info
- When our values align, there's no limit to what we can achieve.
Visa & Work Authorization
- 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 activati
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