Studies Project Manager Health
Sunnyvale, CA - USA
Job Summary
In this dynamic high impact role you will not be confined to a single track. We are looking for a confident strategic leader who can navigate the full spectrum of study execution from architecting study strategy to driving flawless delivery across internal design teams and external partners. You bring proven experience across the human studies research lifecycle deep knowledge of domestic and international regulations and a track record of running both site-based and virtual/remote studies while managing complex amid shifting priorities you toggle seamlessly between granular operational details and executive-level strategy holding partners strictly accountable to timelines budgets and uncompromised data quality. You must navigate severe ambiguity pushing projects forward when hardware specs regulatory pathways or executive mandates are undefined. This role requires you to aggressively drive alignment across engineering data analysis legal and business development stepping in to course-correct when requirements rapidly evolve.
Study Strategy u0026 Execution: Architect and enforce the end-to-end strategy of assigned studies driving strict alignment across internal engineering teams and external partners to hit unyielding milestones and data quality u0026 Budget Management: Own project timelines end-to-end while developing and managing study budgets holding teams and partners accountable to scope and spendnCross-Functional Leadership u0026 Influence: Apply adaptable multi-faceted expertise to align and resolve challenges across diverse teams such as engineering data analysis legal and business development; drive meetings and decisions document action items and progress and deliver clear compelling presentations to senior management on project status and schedules
B.S. degree in biomedical engineering or any engineering discipline or equivalentn7 years of direct experience in clinical project management or clinical operations nStrong human research background with a comprehensive understanding of the end-to-end study lifecycle GCP and domestic/international regulationsnProven track record of scoping evaluating onboarding and managing global CROs and diverse external vendors to successfully deliver on data needs nExperience running virtual and/or remote studies and knowledge on conducting clinical studies with Hardware/Software devices nExperience in budgeting and financial forecasting at a project/study levelnExpert analytical and negotiation skills adept at facilitating actions resolving conflicts and delivering crisp effective communication to executive leadershipnSelf starter and critical thinker with the ability to work autonomously establish priorities and thrive in a highly ambiguous fast paced environmentnSuperb communication skills including effective listening clear and concise writing and the ability to articulate complex project updates to executivesnAbility to be onsite; this role is a hybrid in-person positionnSome travel is required approximately 25%.
Experience leveraging AI digital platforms or advanced analytics in study operationsnExperience with global and/or OUS studies
Required Experience:
IC
About Company
Ask Siri to name the most successful company in the world and it might respond: Apple. And it's not just out of familial pride. Apple consistently ranks highly in profit, revenue, market capitalization, and consumer cachet. In 2018, the company became the first reach a trillion dollar ... View more