Centralized Startup Lead

hace 3 semanas

Buenos Aires, Argentina Sophilabs A tiempo completo

Clinical Trial Amendment Project Lead Essential Job Duties: Primarily oversees and manages amendment phase of domestic and/or international clinical trials. Where required, may also take on start‑up tasks under the direction of a Project Manager, Start‑up. Responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client’s expectations are met. Responsibilities Lead the team through the amendment phase of a study. Activate sites in active start‑up as needed. Serve as the primary client contact with autonomy to interact directly on a broad range of contract amendment issues and decisions. Monitor and control project schedule, proactively identifying risks and ensuring deliverables are met. Engage in quality assurance and risk management activities to maintain project quality. Ensure work is performed within budget, interpreting billing guidelines and tracking financial milestones. Identify and manage potential over‑spending, implementing pre‑ procedures for write‑offs or budget overages. Determine and request project start‑up resources, ensuring effective cross‑functional teamwork among internal and external parties. Escalate non‑compliance related to professional standards, SOPs, or QA requirements, and provide performance feedback to team members. Develop and manage an amendment submission and approval strategy in collaboration with functional groups and the client. Oversee amendment preparation, including ICF updates, ethics/breaks of body submissions, and related documentation. Coordinate query responses and maintain submission timelines. Contribute to a Start‑Up Plan, ensuring sites achieve Ready‑to‑Enroll status on time. Represent the project at external and internal meetings. Qualifications Minimum four (4) years of drug development and clinical research experience (pharmaceutical, biotech, or CRO). Demonstrated skills in study start‑up and/or amendment management. Local project coordination and/or project management experience preferred. Experience overseeing start‑up activities and managing the start‑up workflow. Experience with more than six (6) months of direct sponsor contact. Experience in >1 country for more than six (6) months. Experience in oversight of start‑up activities, especially outside the region. Labcorp is proud to be an Equal Opportunity Employer :As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. #J-18808-Ljbffr

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