20 days old

Clinical Outcomes Project Manager-II

Kelly Services
Malvern, PA 19355
**Seeking a Project Manager-II for a 6 month assignment in Malvern, PA.**

Job Description: The Connected Health Solutions Operations CHS O COA / eCOA Manager is primarily responsible for leading the electronic and paper Clinical Outcome Assessments eCOA/pCOA deliverables to meet the needs of the study/program and internal stakeholders. The incumbent will be required to demonstrate technical expertise in eCOA/ system development, user acceptance testing and provide subject matter expertise to cross functional study teams. The incumbent will lead all eCOA/pCOA-related activities and will be the point of contact for the cross-functional study team. The incumbent is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure Connected Health Solutions Operations CHS O processes are at the best practice level of performance. Serves as a subject matter expert for eCOA/COA, providing advice/recommendation to study teams regarding the suppliers and device/technology alternatives. Completes Requests for Proposal documentation and recommend appropriate suppliers to support study needs. Provides leadership and expertise for the completion of supplier specification development and set-up activities through lifecycle of the trial. For all protocol-dictated COA: research copyright and language availability, ensure permission/licensing, obtain required study translations requires working with preferred translations vendors according to regulations. Leads the cross functional study team through changes of scope for eCOA/pCOA, providing technical expertise on the change of scope, assessment of risk, oversight of system requirements updates and user acceptance testing. Lead the resolution of issues escalated by study teams for processes owned, as well as cross-team specific issues under the supervision of the Director/Associate Director, CHS O. Serves as the point of contact specific to inspection readiness activities between the study team and the eCOA/pCOA suppliers . Effectively manages internal and external business partner relationships in support of R&D Operations deliverables. Monitors key performance indicators KPIs for services provided by suppliers. Conducts Lessons Learned sessions following the completion of study start-up activities, and, as necessary, throughout other phases of the clinical development process. Effectively supports the study team in close-out/deactivation of the ePRO system and archive activities. Provides leadership for supplier assessment/qualification teams. Continually assesses new emerging technologies to optimize operational efficiencies. Represents CHS O as an eCOA/pCOA subject matter expert at internal cross-company meetings and at external professional meetings.


**For immediate consideration, please send your resume in a WORD document to**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-11-25 Expires: 2019-12-26

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Clinical Outcomes Project Manager-II

Kelly Services
Malvern, PA 19355

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