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

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}">&nbsp;</span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div>&nbsp;</div> <div>Led by Tassos Gianakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> 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.</div> <div>&nbsp;</div> <div>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.</div> <div>&nbsp;</div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—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 <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div>&nbsp;</div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div>&nbsp;</div> <div>&nbsp;</div></div><p><strong>Job Title:</strong> Sr. Manager - Project Manager, Digital Health Technology (DHT) &amp; eCOA</p> <p><strong>Position Overview</strong></p> <p><strong>Onsite 4 days a week - M-Th</strong></p> <p>The Project Manager of Digital Health Technology (DHT) &amp; 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.</p> <p><strong>Key Responsibilities </strong></p> <ul> <li>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.</li> <li>Provide technical and operational input directly into protocol development as it relates to digital tools and technologies.</li> <li>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</li> <li>Leverage a deep clinical operations foundation to plan, execute, and monitor proactive mitigation plans for complex operational challenges</li> <li>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.</li> <li>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.</li> <li>Actively monitor and manage all study-level DHT financial components, including contracts, change controls, adjustments, KPIs/KQIs/KRIs, and pass-through costs</li> <li>Provide active operational guidance, training, and technical mentorship to junior Clinical Operations staff.</li> <li>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)</li> <li>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</li> <li>Develop, review, and maintain SOPs, work instructions, and process guidance governing DHT and eCOA implementation, validation, and oversight</li> </ul> <p>&nbsp;</p> <p><strong>Qualifications </strong></p> <ul> <li>Minimum of a BA/BS degree is required (in Life Sciences, Computer Science, Public Health, Information Systems, or a related field).</li> <li>Approximately 8+ years of experience within biotechnology, pharmaceuticals, or clinical trial technology platforms.&nbsp;</li> <li>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.</li> <li>Direct experience participating in or leading ICH/GCP inspections, internal quality audits, and inspection preparedness initiatives.</li> <li>Demonstrated understanding of clinical trial conduct, GCP, and study operations.&nbsp;</li> <li>Strong communication, relationship-building, and presentation skills.&nbsp;</li> <li>Comfort with regional and international travel (up to 25%). &nbsp;</li> </ul> <p>&nbsp;</p> <p><strong>Ideal Candidate Traits </strong></p> <ul> <li>Demonstrated ability to lead and collaborate naturally with cross-functional teams to drive global operational excellence.</li> <li>A data-driven approach to planning, executing, risk mitigation, and technical problem-solving.&nbsp;&nbsp;</li> <li>Solutions-oriented with the confidence to constructively challenge status-quo thinking and behaviors to drive modern, high-efficiency solutions.</li> <li>Thrives on working with agility, adapting quickly to shifting trial environments, and applying an innovative mindset to clinical technology challenges.</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$157,000</span><span class="divider">&mdash;</span><span>$205,000 USD</span></div></div></div>