Regional Site Start Up II - FSP
Parexel
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.
Job description
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.
Site Start Up and Activation
- Accountable to delivering individual site activation timelines to plan for assigned sites
- Gather, organize and share all required essential documents from clinical sites and Sponsor specific documents to ensure compliance with Regulatory and Sponsor requirements
- 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 required in languages other than English for submission to Regulatory Health Authorities and/or Independent Review Board/Ethics Committees
- Provide regional expertise, addressing specific geographic challenges to facilitate site activation; serve as primary point of contact and escalation point for sites
- 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
Requirements
- 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 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
- Support stakeholders by addressing concerns promptly and professionally
- Contribute to team productivity by maintaining open communication and supporting team members
- Bachelor's Degree, minimum
- 3 - 4 years of experience
- Must have experience working with US and Canada
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.