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eCOA Integration Lead

Employer
Cytel - USA
Location
United States;Homeworking
Salary
Competitive
Start date
12 Aug 2022
Closing date
26 Aug 2022

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Job Details

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value, and unlock the full potential of their data.

At Cytel, we work to create successful careers with significant professional growth for our employees. Our Functional Service Provider (FSP) division is seeking an eCOA Specialist who is looking for a career path in helping us build an innovative Data Management FSP Engagement with a pharmaceutical company in Oncology.

This is a Subject Matter Expert level position with hands-on and technical leadership components. This position will report to the VP of FSP in Cytel.

The eCOA, eConscent Implementation Expert

This role directs the technical and operational aspects of Medidata eCOA and eConsent enablement projects and, in collaboration with Programming, leads the development of complex custom reporting to provide adequate sponsor oversight at the site, region, study, and portfolio levels.

Key responsibilities may include :
  • Understands current regulations and best practices for the collection of eSource data and supports inspection readiness as needed.
  • Acts as subject matter expert for study teams and supports the business owner with governance of the Medidata relationship.
  • May contribute to new vendor relationships and implementation documentation
  • Support the development, training and implementation of the eCOA strategy within clinical development across all development phases.
  • Support the Clinical Data Management and Clinical Operations study teams as the eCOA/ePRO point of contact to help implement eCOA/ePRO strategy throughout a clinical trial lifecycle, from system design, study startup, study monitoring, through database lock and any mid-study protocol amendments that require system updates/changes.
  • Execute eCOA/ePRO best practices emphasizing user (site/patient) experience, including technical support for system setup and User Acceptance Testing (UAT), working with service providers to address service issues.
  • Provides process governance and guidance to program and study teams on eCOA implementations.
  • Develop, monitor, and report on performance and quality metrics and compliance.
  • Ensures archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
  • Acts as a process expert for operational activities and oversight of external providers.
  • Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
  • Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
  • Performs other duties as assigned.


Educational qualifications :

  • MS or BS in health-related, life sciences area or technology-related field.


Minimum Work Requirements :

  • Minimum of 6-8 years of eCOA experience with expertise in the cross-functional interfaces with the data management function with at least 4-5 yrs in pharma or CRO.
  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
  • Experience with all phases of development in one or more therapeutic areas preferred.
  • Ability to handle multiple development programs simultaneously.
  • NDA/CTD Experience preferred.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.


Behavioral Competencies :

  • Pragmatic and willing to drive and support change.
  • Is comfortable with ambiguity.
  • Able to influence without authority.
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
  • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.
  • Embody a culture of continual improvement and innovation; promote knowledge sharing.

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