Parexel
Global Site Start Up Lead - FSP
United States - Remote
Sponsorship not specifiedDetected 6 days ago
GCPProject ManagementExcelProcess ImprovementVendor ManagementClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft Office
About the role
- 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.
Responsibilities
- Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks.
- Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions.
- Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
- Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
- Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally.
- Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
- Lead and oversee all aspects of site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
- Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
- Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
- Parexel FSP is looking for Global SSU Leads to join our team in US!
Requirements
- In addition to the core duties outlined, the following qualifications are required for the
- In addition to the core duties outlined, the following qualifications are required for the Global Site Start Up Lead role:
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate across key stakeholders
- Experience in the clinical drug development process, with expertise in study start-up
- Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
- Knowledge of ICH/GCP and regulatory guidelines/directives
- 4-6 years of experience
Benefits
- At Parexel, we all share the same goal - to improve the world's health.
Company info
- When our values align, there's no limit to what we can achieve.
Visa & Work Authorization
- The Global SSU Lead is accountable for ensuring site start-up is efficient, timely and in accordance with Sponsor's Standard Operating Procedures (SOPs) and ICH/GCP
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.