ePRO Manager
ePRO Manager
Posted on :
06-06-2025
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1 Vacancy
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Job Description
Are you a seasoned ePRO expert looking to take ownership of a specialized function in a growing global organization Alimentiv is seeking an experienced ePRO Manager to lead the design implementation and oversight of electronic Patient Reported Outcomes (ePRO) systems in clinical trials.
This is a unique opportunity to leverage your technical and regulatory experience in ePRO within a Full-Service Data Management team with the potential to evolve into a leadership role as our ePRO capabilities expand.
ePRO Implementation & Oversight (6075%)
- Lead all ePRO-related activities in study startup and maintenance including system configuration testing and validation.
- Serve as the subject matter expert (SME) for internal and external stakeholders.
- Define and document system requirements edit checks and study-specific calculations.
- Support CDISC-compliant data mapping and regulatory submission documentation.
- Develop training materials for site staff and participants.
- Act as the main point of contact and escalation for ePRO issues throughout the trial lifecycle.
- Participate in bid defense meetings and client discussions where ePRO is a focus area.
Cross-functional & Strategic Contribution (2540%)
- Contribute to the development and standardization of ePRO processes SOPs and work instructions.
- Collaborate with teams including Clinical Data Standards Database Programming and Regulatory Affairs.
- Lead or support initiatives around innovation and operational excellence in the ePRO space.
- Support business development by consulting on new ePRO opportunities.
QUALIFICATIONS
- 46 years of hands-on experience in ePRO implementation in clinical trials.
- Deep understanding of the ePRO lifecycleincluding system design deployment validation and compliance.
- Familiarity with FDA EMA ICH-GCP and other regulatory frameworks.
- Prior work with external ePRO vendors
- Experience presenting at bid defenses and working with clients.
- Bachelors degree in a scientific or technical field (or equivalent experience)
$78000 - $130000 a year
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams leveraging various methods of attack via email text voice and social media. Please note that Alimentiv only uses company email addresses which contain @ to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv please verify the domain of the senders email address and that they are asking you to apply on this website. If you believe youve been a victim of a phishing scam please contact your local government cyber authority to report.
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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