The Opportunity:

We are seeking a Principal Product Manager, Clinical Trials Intelligence to build products that help teams plan, run, monitor, analyze, submit, and follow clinical trials with greater speed, quality, and confidence.This role will define and deliver product strategy across the clinical trial continuum, from study design and startup through trial conduct, submission readiness, and post-approval safety monitoring. You will shape Clinical Trials Intelligence capabilities on RevCore, our enterprise data and AI platform, with a clear mandate to improve trial execution, enrollment predictability, data readiness, submission readiness, inspection readiness, and safety monitoring.

You will work on high-stakes products where trust, usability, traceability, and speed directly affect trial execution, regulatory readiness, and patient impact. This role focuses on product strategy, user outcomes, workflow design, adoption, and measurable impact, in partnership with clinical, regulatory, safety, medical, data, technology, quality, vendor, and system owner teams.

Own Clinical Trials Intelligence strategy and outcomes

• Define the vision and roadmap across study design, startup, trial conduct, monitoring, data review, submission readiness, and post-approval safety monitoring.

• Build a Now, Next, Later roadmap from foundational clinical data products to operational intelligence, automation, and AI-enabled decision support.

• Set success metrics tied to study startup cycle time, enrollment predictability, data quality, database lock readiness, submission readiness, inspection readiness, safety monitoring, and adoption.

• Prioritize capabilities that reduce manual work, improve clinical decision-making, detect risk earlier, and scale across studies and programs.

Build products around clinical trial workflows and decisions

• Understand workflows across Clinical Development, Clinical Operations, Data Management, Biometrics, Regulatory, Safety, Medical, Clinical Supply, and study teams.

• Design products around key decision moments such as protocol design, site selection, enrollment planning, risk monitoring, data review, database lock readiness, submission readiness, and safety signal review.

• Translate complex clinical trial workflows into clear product requirements, user stories, evaluation criteria, and prioritized capabilities.

• Build products that turn clinical, operational, safety, regulatory, and vendor data into decision-grade insights, not just dashboards or system reports.

Establish trusted, reusable clinical trial capabilities

• Partner with technical teams, vendors, and system owners to deliver priority Clinical Trials Intelligence capabilities across RevCore and core clinical platforms.

• Clarify trusted sources and systems of record for key clinical trial data, including protocols, studies, sites, subjects, visits, endpoints, deviations, adverse events, labs, biomarkers, milestones, and submission artifacts.

• Ensure products support data quality, metadata, lineage, usability, governance, access controls, auditability, traceability, validation, and compliance expectations.

• Determine when to build, buy, partner, or integrate based on user value, vendor maturity, regulatory needs, interoperability, scalability, and maintainability.

Enable self-service intelligence, AI use cases, and adoption

• Enable self-service access, search, semantic discovery, operational intelligence, and “Ask your Clinical Trials data” experiences across priority datasets.

• Use modern AI, analytics, workflow, and low-code tools to prototype concepts, validate user needs, and de-risk ideas before full engineering investment.

• Partner with Data Science and ML Engineering to identify and deliver high-value AI and GenAI use cases such as protocol intelligence, enrollment forecasting, risk detection, data review copilots, submission readiness support, safety summarization, and post-approval monitoring insights.

• Drive rollout, adoption, and continuous improvement through usage metrics, feedback loops, training, and measurable workflow improvements.

Required Skills, Experience and Education:

• 12+ years of experience in Product Management, Clinical Data Product Management, Clinical Informatics, Clinical Operations Technology, Clinical Systems, Digital Health, Life Sciences Data Platforms, or related roles within biotech, pharma, CRO, healthcare technology, or another regulated environment.

• Strong product leadership experience, including defining vision, shaping strategy, building roadmaps, prioritizing tradeoffs, influencing senior stakeholders, and delivering measurable outcomes across complex domains.

• Deep understanding of clinical trial workflows across study design, startup, conduct, monitoring, data management, analysis, submission, and post-approval safety monitoring.

• Experience translating clinical trial workflows into scalable product capabilities, user stories, evaluation criteria, and product requirements.

• Working knowledge of clinical data and systems, including CTMS, EDC, eTMF, IRT/RTSM, eCOA/ePRO, safety systems, clinical data repositories, statistical programming environments, and vendor data feeds.

• Strong understanding of clinical data quality, governance, metadata, lineage, interoperability, access controls, auditability, validation, and regulated system expectations.

• Product judgment to evaluate build, buy, partner, and integration options based on user value, market maturity, compliance needs, scalability, interoperability, and maintainability.

• Strong communication and stakeholder management skills across clinical, regulatory, safety, medical, technical, quality, vendor, and executive audiences.

• Bachelor’s degree or equivalent experience in Life Sciences, Clinical Research, Public Health, Pharmacy, Medicine, Computer Science, Information Systems, Engineering, or a related field.

Preferred Skills:

• Experience delivering enterprise clinical data products, clinical intelligence platforms, clinical operations analytics, or AI-enabled clinical decision-support products.

• Experience with oncology clinical development, precision medicine trials, biomarker-driven studies, complex trial designs, or global clinical operations.

• Familiarity with clinical standards and regulatory expectations such as CDISC, SDTM, ADaM, controlled terminology, GxP, 21 CFR Part 11, GDPR, HIPAA, ICH GCP, or related requirements.

• Experience evaluating, implementing, or integrating SaaS platforms and vendor solutions across clinical operations, clinical data management, regulatory, safety, or medical workflows.

• Experience using modern AI, analytics, workflow, and low-code tools to prototype product concepts, validate user needs, and de-risk ideas before full engineering investment.

• Comfort operating in an emerging biotech environment where strategy, execution, ambiguity, compliance, vendor complexity, and hands-on problem solving all matter.

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