layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Sr. Manager - Project Manager, Digital Health Technology (DHT) & eCOA at Kardigan | LAYIQ

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

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

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