Regional Site Start Up II to join our team in
US or Canada.Job SummaryThe
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.
