Sr Project Manager, Digital Health Technology (DHT) & eCOA
Eliassen Group
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 -84 Responsibilities:
Experience Requirements:
Education Requirements:
Minimum BA/BS in Life Sciences, Computer Science, Public Health, Information Systems, or related field. Recruitment Transparency Notice Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team ( , ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process. Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range. W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following: When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc. Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact . About Eliassen Group: Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve. Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws. Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
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 -84 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-Google Cloud Platform, 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/Google Cloud Platform inspections, internal quality audits, and inspection preparedness initiatives.
- Demonstrated understanding of clinical trial conduct, Google Cloud Platform, 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. Recruitment Transparency Notice Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team ( , ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process. Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range. W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following: When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc. Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact . About Eliassen Group: Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve. Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws. Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
Vacancy posted 2 hours ago
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