[Remote] Principal Clinical Project Manager

Note: The job is a remote job and is open to candidates in USA. Olympus Corporation is a global medical technology company focused on improving patient outcomes through innovative solutions. They are seeking a Principal Clinical Project Manager to oversee the operational execution of complex clinical trials, ensuring timely delivery, budget management, and regulatory compliance while coordinating cross-functional teams.ResponsibilitiesLead operational execution of complex clinical trials from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestonesServe as the central hub for the study core team, coordinating activities across Clinical Strategy, Data Management, Biometrics, Monitoring, Site Management, Data Systems, and Clinical Trial AssociatesEnsure cross-functional alignment and accountability for study deliverables, tracking progress across functional areas and escalating risks, delays, or resource constraints to functional leadership when neededOversee end-to-end clinical trial operations, including site start-up, contract and site budget review processes, enrollment progress, monitoring strategy, vendor performance, and study closeoutManage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study financial performanceCoordinate the development of key study documents and operational plans, including protocols, CRFs, informed consent form (ICF), monitoring plan, data management plan, training plan, safety plan, etcCoordinate safety oversight activities, supporting collaboration with Safety and Medical teams and operational coordination of DSMB, CEC, and other study governance committeesEnsure data integrity, regulatory compliance, and inspection readiness, partnering with Data Management, Biometrics, and Clinical Quality Assurance (CQA) to support data review, safety reporting, protocol deviation management, and audit preparednessManage CROs and external vendors, ensuring adherence to study plans, timelines, and performance expectationsCommunicate study status, risks, and key milestones through regular reporting and presentations to internal stakeholders and senior leadershipSupport investigator and site engagement, including investigator meetings, site training coordination, and enrollment oversightProvide mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processesSkillsBachelor's degree in health sciences or related field and 12+ years of clinical trial management experience or an equivalent combination of education and work experienceFinancial acumen required; Clinical trial budget management experience requiredExpertise with complex clinical research guidelines (i.e., 21CFR 312/812, ISO 14155, GDPR, GCP)Experience managing scope, budget and timelineHas experience tackling challenging business problems that impact multiple teamsAble to communicate effectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high levels of emotional intelligenceProficient computer skills (Electronic Data Capture, Microsoft Word, Excel, PowerPoint, MS Project, etc.) Strong organizational skills with high attention to detail and degree of accuracySkilled at collaborative and individual problem solvingStrong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials, which includes applicable ISO regulations for any trials conducted globallyExperience coordinating, prioritizing, setting timelines, and multi-tasking Professional demeanor and appearanceAbility to expertly create and deliver communication to all levels of leadership with the appropriate level of detail for the audienceDemonstrate the ability to resolve conflict, influence teams, and build relationships in meeting organizational objectives without formal authorityAbility to work independently and manage multiple tasks in a fast-paced environmentAbility to work with and effectively manage cross-functional teamsAbility to travel domestically up to 20-40% of the time. Some international travel up to 10%, may be expectedPrevious experience with medical device trialsLeadership – indirect or direct people leadership – ability to influenceMS/MPH degree in life sciences, or related fieldParticipation on a product development (PDP) core team representing Clinical, strongly preferred. Has consistently delivered projects with broad business impact across multiple teamsBenefitsCompetitive salaries, annual bonus and 401(k) with company matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance12 Paid HolidaysOn-Site Child Daycare, Café, Fitness CenterWork-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsEmployee Resource GroupsDedicated Training Resources and Learning & Development ProgramsPaid Educational AssistanceUS OnlyCenter Valley, PA and Westborough, MACompany OverviewOlympus is passionate about creating customer-driven solutions for the medical industry. It was founded in 1919, and is headquartered in Shinjuku, Yamanashi, JPN, with a workforce of 10001+ employees. Its website is https://heylink.me/yokubet.id/.