Associate Start Up Lead

The drug and diagnostic development businesses of Precision Medicine Group, collectively known as Precision for Medicine, are industry leaders in the design, development, and execution of biomarker-informed clinical studies and complex data management. Our best-in-class CRO services ensure clients accelerate time to market while reducing costs and minimizing risk.

The Associate Start Up Lead is experienced in driving country and/or regional site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and delivery of quality IMP release packages. The Associate Start Up Lead may also have global exposure to CA/ MoH submissions. Will act as Subject Matter Expert for questions by other in-country members (RSSs, CRAs, PSSs or others) supporting site start-up activities, may support development 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. 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. Maintain communication with other key functions participating to 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. Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. May mentor staff on local study start-up regulations, submissions, internal procedures and SSDL. Interact with clients in proposal activities, including slide development and client presentation as required. Performs other duties as assigned by management