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DOCS IRT/IxRS Project Manager in Lansing, Michigan

IRT/IxRS Project Manager

Ref #: 25842

Employment type: Permanent - Full-Time

Location: US - Nationwide

Posted: 06-Jan-2021


Icon/DOCS is currently searching for an experienced IVRS/IRT Project Manager.

• Provide Advice/recommendation to study teams regarding the supplier and system design alternatives.

• Provide Requests for Proposal documentation, and recommend appropriate suppliers to support study needs.

• Provide leadership and subject matter expertise for the completion of supplier set-up activities through lifecycle of the IVR/IWR system.

• Lead the cross functional study team through changes of scope for IVRS/IWRS, 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 as well as cross-team specific issues under the supervision of the Director or Associate Director, RTSM as applicable.

• Demonstrate sufficient knowledge of randomization and medication assignment processes to be able to perform required un-blinded assessments of the IVR/IWR system performance (or functionality) should that be assigned.

• Serve as the point of contact specific to inspection readiness activities between the study team and the IVRS/IWRS supplier.

• Effectively manage internal and external business partner relationships in support of R&D Operations' deliverables.

• Monitor key performance indicators for services provided by external service providers.

• Conduct Lessons Learned sessions following the completion of study start-up activities, and, as necessary, throughout other phases of the clinical development process.

• Effectively support the study team in close-out/deactivation of the IVR/IWR system.

• Continually assess new emerging technologies to optimize operational efficiencies.

• Represent PDMS as an IVR/IWR expert at cross-company meetings and at external professional meetings.

• Ensure that principles of Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships.

• Metrics/KPls governing these services are maintained in the RTSM Metrics Spreadsheet.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.