Description
Remote
Our client seeks a Sr Project Manager, Digital Health Technology (DHT) & eCOA for a 12-month remote contract. The role serves as a bridge between clinical operations, data management, clinical quality, and external technology partners with accountability for implementation quality and compliance of patient-facing digital tools. The position combines a clinical operations background with specialized expertise in eCOA systems and wearable device development processes, managing the technical trial lifecycle from study design through close-out with an agile and innovative mindset.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $80.00 to $95.00/hr. w2
JN -092026-108484
Responsibilities
- Serve as the primary operational SME and escalation point for assigned digital health technologies, including eCOA (ePRO, ClinRO, ObsRO), eConsent, wearables, and sensors.
- Provide technical and operational input into protocol development related to digital tools and technologies.
- Own end-to-end technical project timelines, author, review, and approve study specifications and user requirements, execute UAT, and manage acquisition of COA instrument licenses.
- Plan, execute, and monitor proactive mitigation plans for complex operational challenges using a clinical operations foundation.
- Liaise with cross-functional teams to ensure cohesive trial execution, align technical data flows with the Medical Monitoring Plan, and oversee monitoring as it pertains to digital tools, data compliance, and site performance.
- Directly manage specialized vendor performance, conduct root cause analyses for system variances, implement CAPAs, and provide technical problem resolution.
- Monitor and manage study-level DHT financial components including contracts, change controls, adjustments, KPIs/KQIs/KRIs, and pass-through costs.
- Provide operational guidance, training, and technical mentorship to junior Clinical Operations staff.
- Partner with Clinical Quality to align DHT processes with internal quality systems, inspection readiness, and evolving regulatory guidance (ICH-GCP, eCOA-related expectations).
- Lead or contribute to risk assessments for digital technologies and incorporate findings into study-level and program-level risk management plans.
- Develop, review, and maintain SOPs, work instructions, and process guidance for DHT and eCOA implementation, validation, and oversight.
Experience Requirements
- Minimum of approximately 8+ years within biotechnology, pharmaceuticals, or clinical trial technology platforms.
- Proven track record managing trials with a multi-dimensional Clinical Operations background 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.
- Ability to lead and collaborate with cross-functional teams to drive operational excellence.
- Data-driven approach to planning, execution, risk mitigation, and technical problem-solving.
- Solutions-oriented with the ability to challenge status-quo thinking to drive high-efficiency solutions.
- Agility to adapt to shifting trial environments with an innovative mindset.
Education Requirements
Minimum BA/BS in Life Sciences, Computer Science, Public Health, Information Systems, or related field.