Clinical Study Operations Engineering Program Manager Health

Apple Healths ever-evolving suite of health and wellness products are helping our users live more active healthier lives. Be ready to make something great when you come here. Dynamic inspiring people and innovative industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found Health Group conceives of and proves out exciting new technologies for Apples future products and features. We are seeking a highly strategic Clinical Study Operations Engineering Program Manager to provide flexible oversight across our study portfolio. Acting as a critical bridge between recruitment partner management and study execution you will drive the onboarding of global CROs define early-stage recruitment pipelines/channels leverage advanced analytics to extract predictive insights and generate strategic recommendations and lay the groundwork for international (OUS) expansion on the recruitment front day to day operations of running studies and comprehensive data management oversight.

In this dynamic high impact/fast paced role you will not be confined to a single track. We are looking for a strategic powerhouse who can tackle complex challenges across the entire clinical study portfolio. You bring proven experience in establishing robust operational pathways working with Clinical Research Organizations (CRO) from architecting innovative recruitment strategies to custom building global partner relationships. Thriving in the unknown you will seamlessly map future OUS expansions and deploy your versatile expertise to lead high-priority studies fluidly adapting to drive success in any capacity required. This role is meant for you if you thrive holding partners accountable digging deep into data and extracting key strategies and recommendations while continuously meeting timelines and data

Global Partner Onboarding u0026 Strategic Alignment: Drive the qualification of global CROs and niche recruitment partners acting as the primary architect of their operational engagement. Establish robust executive relationships and strategically engineer their processes workflows and staffing to build dedicated teams that align with our unique requirements and ensure excellence in executionnEnd-to-End Recruitment Strategy: Embed deeply with cross-functional teams during early feature design to establish recruitment strategies and build pipelines tailored to specific data requirements. Drive the enhancement of current recruitment models by leveraging strong analytics extensive participant evaluations and integration of AI nOUS Strategy u0026 Expansion: Map successful US recruitment and operational methodologies to OUS regions building the foundational relationships and frameworks required to prepare for future international studiesnData-Driven Study Analytics: Define overall metrics and data visualization frameworks at study inception to drive clear strategy definition generate actionable insights and enable agile pivoting during executionnData Management Governance u0026 Oversight: Direct the overarching data management strategy and execution across internal teams and external CROs. Ensure robust data integrity and adherence to internal standards by guiding the key pillars of data management holding partners accountable and securing adequate data management resourcing for all assigned projectsnVersatile Study Leadership u0026 Influence: Apply adaptable multi-faceted expertise to manage complex high-priority studies and seamlessly bridge diverse disciplines. By tailoring communication and leading through influence align cross-functional teams across engineering clinical legal and business development to resolve unpredictable operational challengesn

B.S. degree in biomedical engineering or any engineering discipline or equivalentn10 years of direct experience in clinical project management strategic partnerships or clinical operations within Health or TechnologynStrong human research background with a comprehensive understanding of the end-to-end study lifecycle GCP and domestic/international regulationsnProven track record of managing and onboarding global CROs and diverse external vendorsnAbility to knit together disparate sources of information into a strong strategic narrative and perform data analysis to drive measurable resultsnExpert analytical and negotiation skills adept at facilitating actions resolving conflicts and delivering crisp effective communication to executive leadershipnProven ability to project manage and oversee clinical data management activities ensuring adequate resourcing vendor compliance and strict data integrity across the study 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 clinical recruitment and study operationsnDirect experience strategizing and mapping clinical operations for OUS regions