Laboratory Project Services Manager, based in Livingston, West Lothian

IQVIA ,
Livingston, West Lothian
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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. PURPOSE As lead Global Project Manager or Regional PM, manage internal laboratory teams to ensure successful delivery of all study activities. Act as main point of contact for clients post study award and throughout the entire study lifecycle (startup, maintenance, close-out). RESPONSIBILITIES 1. Study Setup and Planning a. Manage individual clinical trial projects as assigned. b. Facilitate Seamless Study Set-Up i. Review study protocol and bid/budget information once a study is awarded. ii. Ensure initial meetings are conducted (e.g. document review meetings, Design, or Startup meetings) with sponsor, Protocol requirements are understood and applied to the design of the lab study, and relay lab processes to the client. iii. Consult and advise client on best or most proper course of action as needed. iv. Develop, relay and implement the Project Management Plan and Risk Management Plan per study as applicable; Create cost containment measures. v. Partner with Study Set-Up team to ensure quality of study set-up. c. Participate in proposal and the business development processes as applicable to Project Services responsibilities. d. Perform the technical review at program / project initiation and provide input into project proposals as well as lead discussions around budget implications and changes e. Ensure key milestones are met and appropriate resources are available. f. Oversee the writing of protocol-specific laboratory instructional materials (e.g. manuals, flowcharts, etc.) and participate in the preparation and maintenance of the laboratory specification documents. 2. Study Activity Monitoring and Closeout a. Monitor Project Management Plan, timelines, and deliverables, including trend analysis of study specific data. b. Manage study scope changes and study budget. c. Utilize available tools, metrics, and reports as part of global study monitoring and closeout. d. Manage all service related issues and implement changes to plan as required. e. Conduct meetings with internal departments as required to meet needs of study and closeout activities. f. Monitor quality of study and proactively determine and implement solutions for any issues that arise. g. Report study progress to internal and external clients. h. Ensure lessons learned are considered, shared and improvements included in processes, as applicable. 3. Proactive lines of communication a. Build and own client relationship for assigned study and serve as a liaison between Sponsor and project teams. b. Facilitate Communication with the Client. i. Act as the single point of contact for client, both responding and triaging communications. ii. Lead and/or participate in key client facing meetings (investigator meetings, study meetings, etc.). iii. Travel and present lab services at client meetings; provide support to sales for bid defenses and capabilities presentations. c. Coordinate customer survey follow-up/ongoing health check calls and overall client relationship building. d. Lead problem solving and resolution efforts in a timely, client-focused manner. e. Serve as a liaison between Sponsor and project teams; Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. f. Serve as a point of escalation for program level issues, while ensuring consistency of delivery on a global level. g. Coordinate and Triage Study-specific issues. i. 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. Develop proactive contingency plans to mitigate laboratory risk. ii. Escalate issues that impact the study plan or budget and relay any issues or trends to clients as applicable. iii. Facilitate regular review meetings to discuss proactive problem resolution of study specific issues, utilizing the necessary resources from all relevant internal departments. 4. Project Documentation and Deliverables a. Coordinate meeting agenda, document minutes, track actions, and provide status updates. b. Oversee the writing of protocol-specific laboratory instructional documents (e.g. manuals, flowcharts) and participate in the preparation and maintenance of the laboratory specifications document for each assig

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