Epro Project Manager

PRA Health Sciences Philadelphia , PA 19107

Posted 3 weeks ago

Who are we? We Are PRA. We are 17,000+ employees strong, operating in more than 90+ countries. PRA is committed to saving lives and constantly striving to be the best at what we do. Our impact is real, and we see it every day. We help get life-saving drugs into the hands of those who need them most.

We are currently hiring for a senior-level Global ePRO / eCOA Project Manager. This is an excellent opportunity for career development, as our company continues to grow. This particular role will be part of a dedicated Data Management team and support an embedded client, a global Pharmaceutical company.

  • Manage translation process and timelines with vendors

  • Kickoff ePRO development

  • Draft/finalize user requirement specifications

  • Execute UAT scripts / change requests

  • Establish Project Plan via Microsoft Project

  • Manage ePRO project schedule

  • Coordinate resolution & risk mitigation of all ePRO / eCOA-related issues and end-of-study vendor deliverables

  • Write / update SOPs and develop a library of ePRO data capture and reporting standards, as needed

  • Provide support to the IVRS team, as needed

  • Work with Vendor PMs to maintain timelines and determine resources

  • Ensure sites/patients have device inventory

  • Manage new requirements / regulations across multiple countries

  • Support ongoing maintenance / database lock activities

  • Serve as ePRO Subject Matter Expert

  • Manage the decommissioning process with the eCOA vendor, at study close-out.

Required Experience:

  • 3 to 5+ years working on clinical studies

  • electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient-Reported Outcome (ePRO) experience

  • 2 to 3+ years of project management and vendor management

  • Study protocol analysis experience, including requirements extraction for COA builds and creation / implementation of study design plans

  • Translation knowledge & experience, including experience working with translation teams/vendors

  • Execution of UAT Scripts and/or Change Requests

  • Solid study start-up experience, including having led cross-functional kickoff meetings for EDC, ePRO and/or eCOA activities

  • Study close-out experience, including: international device shipping (returns), archiving, risk mitigation, and management of decommissioning activities with eCOA vendor

Preferred Experience:

  • InForm EDC

  • MS Project

  • Global management of regulations and requirements

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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Epro Project Manager

PRA Health Sciences