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Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential ...
JOB DESCRIPTION
RESPONSIBILITIES
Serve as point of contact and manage delivery of sponsor in-house projects within the FSP contract through full Data Management scope per agreed upon timelines, resource needs, best practices and with quality per FSP guidance and requirements.
Manage full life cycle of Data Management deliverables including CRF/e-CRF, database design and set-up, user acceptance testing (for trials in start-up and post-production changes for trials in conduct) and programming specifications, Data Management Plans, and database deliverables where applicable (excluding ALL project financial tasks).
Conduct comprehensive data management tasks including but not limited to data reconciliation, metric reporting, data review, writing and resolving data clarifications.
Establish strong communication with DM Support, Clinical Trial Lead (CTL), all core and extended CTT team members and functional leads as necessary to ensure all milestones/deliverables are met.
Manage process improvements and workload projections by provide LEAN/technical advice to solve problems and improve efficiency within the FSP and help others through the learning curve to achieve trial goals with subsequent implementation.
Provide comprehensive technical expertise to the DM Support, Programmer/Database Developer and Clinical Trail Team (CTT) and interact as need be.
Create and/or review and sign-off on all FSP data management plans and other relevant trial documents.
Serve as the escalation point for unresolved data issues working with CTL, DM support, vendors, and CTT as needed to ensure root cause identification, timely follow-up, and implementation of remedial actions/resolution of issues.
Escalate problems/issues to the attention of the PCDM/Engagement Manager and Data Analytics and Review Team (DART).
Comply with all IQVIA Corporate Policies, FSP specific Sponsor Standard Operating Procedures (SOPs)/Working Practices (WPs), FSP curriculum and key performance indicators.
Train, mentor and provide leadership to fellow FSP team associates on data management skills and processes.
Collaborate with TDM(s) to ensure DB start-up activities & Go-Live dates, deliverables and all milestones are met as per agreed upon timelines and per FSP standards.
As a LEAN practitioner and FSP ambassador identify and support initiatives and process improvement strategies that can assist project teams in achieving their goals and set FSP expectations.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
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