Key Responsibilities:
* Develop and implement global site start-up strategies to ensure efficient initiation of clinical studies.
About the Role:
The Site Start-Up Manager oversees and manages the critical phase of clinical studies, ensuring all startup activities are completed in compliance with regulatory requirements. This role contributes significantly to the successful execution of clinical trials.
Key Objectives:
* To define, develop, and deliver a comprehensive global site start-up plan.
* To analyze clinical trial data and apply it for accurate study start-up forecasts.
* To drive rapid, accurate, and data-driven study start-up forecasts, benchmarking assumptions, scenarios, and accurate planning.
* To design creative processes, methodologies, data, and technologies to guarantee ongoing delivery of valued Site Start-Up Services.
Accountabilities:
* Establish, develop, and deliver the Global Site Start-Up Plan.
* Partner with Clinical Operations teams and other stakeholders to improve overall site start-up metrics and implement processes.
* Provide guidance, oversight, and training to the Site Start-Up team, supporting Clinical Programs by delivering activities such as data and methodologies for protocol study start-up, country and site selection, study start-up planning, and modeling.
* Ensure standards are applied to the study start-up process across project portfolios and support continuous improvement activities while developing aligned strategies.
* Leverage leading industry tools and data sources to provide data on start-up timelines and performance (data quality, start-up cycle time) to assist project teams with site initiation timeline forecasting.
* Agree to deliverables on a site-level basis with the SSU team and monitor adherence to these. Promptly recognize and improve potential delays and escalate non-performance.
* Lead the site start-up team, using appropriate team members to help implement the Site Start-Up Plan.
* Drive delivery of all supported sites that are "Ready To Enroll".
* Resolve escalated issues identified by the site start-up team in partnership with the Study Manager.
Requirements:
* Bachelor's degree or international equivalent in a life science.
* Four or more years of experience in Clinical Operations, Project Management, site start-up, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO, or relevant industry vendor.
* At least two years of direct responsibility in site activation and managing the site start-up processes of clinical research studies at a sponsor or CRO.
* Proficiency with software models and database structures.
* Global SSU experience preferred.
* Ability to explain data, facilitate decision-making processes to be data-driven.
* Expertise in principles driving country/site start-up and study start-up strategies.