Senior Site Activation Specialist
hace 4 semanas
Job Summary
The Precision Medicine Group is seeking a highly skilled Senior Site Activation Specialist to lead site start-up activities globally. This role requires a strong passion for site activation and the ability to work remotely in various countries.
Key Responsibilities
- Develop and execute site start-up strategies and plans, including coordination of Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/MoH submissions, and delivery of quality IMP release packages.
- Act as Subject Matter Expert for questions by other in-country members, supporting site start-up activities, and may be identified as Owner of country-specific tools and guidance documents to increase knowledge share of country-specific site start-up activities.
- Manage the site start-up process through development of an activation readiness strategy to enable oversight of site start-up delivery.
- Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start-up activities to allow on-time activation.
- Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start-up.
- Partner closely with Functional Leaders and Site Start-up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
- Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real-time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
- Responsible for coordinating translations for documents required for submissions.
- Maintain communication with other key functions participating in country start-up, i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project-specific status and deliverables.
- Act as SME for collection and maintenance of site-level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts, and budget negotiation requirements that may be in place as well as other start-up requirements for assigned country.
- If needed, directly support country or site-level activities start-up activities.
- Support development of country-specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
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