Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location: Based in Australia/Singapore/South Korea/Taiwan/China. Position Summary The Start Up (SU) Lead is an expert in global 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 CA/MoH submissions and delivery of quality IMP release packages. The SU Lead acts as a subject matter expert for questions by other in‑country members (SUSs, CRAs, CSSs, etc.), trainer for less‑experienced staff on site start‑up activities, and may be identified as the owner of country‑specific tools and guidance documents to increase knowledge sharing of country‑specific site start‑up activities. Essential Functions 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, ICF customization, risk mitigations, IMP release requirements and contract execution. Collaborate and communicate with stakeholders to secure input for milestone planning, and align operational goals to ensure timely delivery of site start‑up activities. 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 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. Coordinate translations for documents required for submissions. Maintain communication with other key functions participating in country start‑up (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/EC timelines, other required reviews, site contracts and budget negotiation requirements. Directly support country or site‑level activities when needed. 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. 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. Qualifications Minimum Required Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training and experience. 5 years or more in start‑up, ideally with SU Lead or PM experience in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies. 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities. Other Required Demonstrated leadership experience in driving cross‑functional activities. Excellent communication and organizational skills. Experience using computerized information systems, electronic spreadsheets, word processing and email. Fluency in English and, for non‑English speaking countries, the local language of the country where the position is based. Experience using milestone tracking tools/r systems. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. #J-18808-Ljbffr