Kardigan

Kardigan

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

Princeton, NJ · Senior

Sponsorship not specified$157k-$205kDetected 22 days ago
GCPProject ManagementPublic HealthResearchExperimental DesignCommunicationMentoring

About the role

  • We believe in being authentic -leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted.
  • With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds.
  • These values are the foundation of our work, empowering us to make a real difference, every day.

Responsibilities

  • 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
  • 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
  • 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

Requirements

  • 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.
  • Comfort with regional and international travel (up to 25%).
  • Ideal Candidate Traits
  • Minimum of a BA/BS degree is required (in Life Sciences, Computer Science, Public Health, Information Systems, or a related field).
  • 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.
  • 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.

Compensation

  • $157,000 - $205,000 USD

Benefits

  • 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.

Company info

  • Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
  • It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
  • Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
  • We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
  • At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals.
  • Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else.
  • We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit.
  • Lastly, we strive to enable the impossible because patients are counting on us.
  • We are not afraid to take risks to unlock innovation and advance scientific discoveries.
  • Job Title: Sr.
  • Manager - Project Manager, Digital Health Technology (DHT) & eCOA
  • Position Overview
  • Onsite 4 days a week - M-Th
  • The Project Manager of Digital Health Technology (DHT) & eCOA will serve as a critical bridge between clinical operations, data management, clinical quality, and external technology partners, holding ultimate accountability for the successful implementation, quality, and compliance of patient-facing digital tools.
  • This role combines a clinical operations background with deep specialized expertise in eCOA system, and wearable device development processes.
  • The ideal candidate will manage the technical trial lifecycle from study design to close-out.
  • This role requires an agile, innovative mindset to challenge status-quo thinking and requires travel-up to 25%-to support investigator meetings, vendor audits, and internal initiatives.
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