Sr. Manager - Project Manager, Digital Health Technology (DHT) & eCOA

Kardigan•Princeton, NJ

11h•$157,000 - $205,000•Onsite

About The Position

Kardigan is a heart health company dedicated to preventing and curing cardiovascular disease. The company is led by experienced co-founders who previously led MyoKardia to develop mavacamten. Kardigan possesses a strong discovery and research platform, a promising pipeline, and a driven team focused on patient well-being. The company's values—patient-centricity, authenticity, eagerness to learn, teamwork, and enabling the impossible—guide their work and commitment to making a significant difference in patients' lives.

Requirements

Minimum of a BA/BS degree is required (in Life Sciences, Computer Science, Public Health, Information Systems, or a related field).
Approximately 8+ years of experience within biotechnology, pharmaceuticals, or clinical trial technology platforms.
Proven track record of managing trials with a multi-dimensional Clinical Operations background (site activation, enrollment, data flows) and deep mastery of eCOA systems development.
Direct experience participating in or leading ICH/GCP inspections, internal quality audits, and inspection preparedness initiatives.
Demonstrated understanding of clinical trial conduct, GCP, and study operations.
Strong communication, relationship-building, and presentation skills.
Comfort with regional and international travel (up to 25%).

Nice To Haves

Demonstrated ability to lead and collaborate naturally with cross-functional teams to drive global operational excellence.
A data-driven approach to planning, executing, risk mitigation, and technical problem-solving.
Solutions-oriented with the confidence to constructively challenge status-quo thinking and behaviors to drive modern, high-efficiency solutions.
Thrives on working with agility, adapting quickly to shifting trial environments, and applying an innovative mindset to clinical technology challenges.

Responsibilities

Serve as the primary operational Subject Matter Expert (SME) and escalation point for assigned digital health technologies, including eCOA (ePRO, ClinRO, ObsRO), eConsent, wearables, and sensors.
Provide technical and operational input directly into protocol development as it relates to digital tools and technologies.
Own end-to-end technical project timelines, authoring, reviewing, and formally approving study specifications, user requirement documentation, and the execution of User Acceptance Testing (UAT), including managing the acquisition of COA instrument licenses.
Leverage a deep clinical operations foundation to plan, execute, and monitor proactive mitigation plans for complex operational challenges.
Liaise with cross-functional team representatives and study teams to ensure cohesive trial execution, align technical data flows with the study's Medical Monitoring Plan, and oversee the execution of the study monitoring plan as it pertains to digital tools, data compliance, and technical trial site performance.
Directly manage specialized vendor performance at the trial level, conducting root cause analyses for system variances, identifying and implementation of corrective actions (CAPAs), and providing technical problem resolution support.
Actively monitor and manage all study-level DHT financial components, including contracts, change controls, adjustments, KPIs/KQIs/KRIs, and pass-through costs.
Provide active operational guidance, training, and technical mentorship to junior Clinical Operations staff.
Partner with Clinical Quality to ensure DHT processes align with internal quality systems, inspection readiness expectations, and evolving regulatory guidance (ICH-GCP, eCOA-related expectations).
Lead and/or contribute to risk assessments for digital technologies (e.g., data integrity, patient compliance, device reliability), incorporating findings into study-level and program-level risk management plans.
Develop, review, and maintain SOPs, work instructions, and process guidance governing DHT and eCOA implementation, validation, and oversight.