Clinical Trial Operations Lead

6+ years of experience in clinical trial operations with at least 4 years in lead roles, clinical research, or clinical study management within digital health, medical devices, SaMD, biotech, pharmaceuticals, or another regulated healthcare environment.

Demonstrated experience managing clinical studies end-to-end, including study start-up, execution, monitoring, and closeout.

Demonstrated experience executing decentralized and/or hybrid clinical trials, including participant-facing operations, remote data collection, digital study technologies, and direct-to-participant research workflows.

Strong working knowledge of ICH-GCP, FDA regulations, IRB requirements, informed consent, and clinical research documentation.

Experience working directly with clinical research sites, investigators, CROs, and external study vendors.

Experience managing study timelines, budgets, enrollment targets, operational metrics, risks, and dependencies.

Strong understanding of clinical data collection and data-quality processes.

Excellent project and program management skills with exceptional attention to detail.

Ability to create structure in an ambiguous environment and manage multiple priorities simultaneously.

Strong written and verbal communication skills and the ability to work effectively with clinical, technical, scientific, and operational stakeholders.

A hands-on approach and willingness to own both strategic planning and detailed execution.

Bachelor’s degree in life sciences, health sciences, clinical research, public health, or a related field, or equivalent relevant experience.

Experience running clinical studies for digital health, AI-enabled healthcare, Software as a Medical Device (SaMD), remote patient monitoring, or connected medical device products.

Experience implementing and managing digital clinical trial technologies, including EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring, wearables, or connected devices.

Experience designing participant-centric clinical research models that reduce reliance on traditional site-based study visits.

Experience working with academic medical centers and health-system research teams.

Experience supporting randomized controlled trials and/or studies intended to support regulatory submissions or peer-reviewed publications.

Experience establishing clinical operations processes at an early-stage company or building a clinical trial function from the ground up.

Experience working closely with Product, Engineering, Data Science, or AI/ML teams.

Advanced degree (MPH, MS, RN, PharmD, PhD, or similar) and/or clinical research certification such as CCRC, CCRP, or equivalent.