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17846-Assoc Lab Project Set-Up Mgr (R1058169) in Beijing, China at IQVIA™

Date Posted: 2/14/2019

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Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable.
 Perform database configuration and programming review and approve verification unit testing while adhering to the database design requirements.
 Collaborate with senior colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.
 Responsible for updates to the project tracking database, action/issues logs, status sheets and timelines during the set up phase.
 Communicate and coordinate set-up activities with clients and internal customers to ensure approvals are met, launch is successful, and a seamless transfer of the project to the Project Manager.
 Lead in the development of sponsor specific standards and program-specific set-up procedures.
 Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally.
 Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate.
 As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.).
 Participate in external and internal audits as required.
 Coordinate and mentor more junior staff; may assist in training new staff on assigned to projects.
 Report on team performance against contract, customer expectations, and project baselines to management.

Job ID: R1058169