- Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
- Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy (if assigned to global study), ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
- 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 to co-ordinate translations for documents required for submissions.
- 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.
- Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.