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Global Clinical Study Manager

Company: IQVIA
Location: Somerville
Posted on: January 12, 2021

Job Description:

PURPOSE In this important, high-profile role within IQVIA you will become an integral member of our Project Team. As a Global Study Manager, you will drive the delivery of clinical studies and help bring new therapies to market faster, ultimately improving patients--- lives throughout the world. This role will maximize your strong vendor management skills and your ability to influence and liaise with multiple leaders across IQVIA functions. Candidates with strong budget, time management, and communication skills, as well as those comfortable acting as the accountable point of contact for their customers will succeed in this position. You will be supported by domain experts in every function and enabled by best-in-class technology to ensure the overall project meets delivery requirements.RESPONSIBILITIESGeneral GSM ResponsibilitiesOversight of all vendors. Develop scope of work, budgets, and change orders (due to amendments). Integral part of study management team (SMT) including Biosafety, Clinical Scientists, Regulatory, Data Management, and GSL (Global Study Lead). Collaborate with other functional groups such as the Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilence, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.Oversee CSMs (Country Study Managers) to ensure protocol/amendments are approved by IRBs, continuous data flow, and escalated issues are communicated to the SMT (Study Management Team). Working with Data Management to ensure continuous review of data especially for data locks/snap shots. Study start-up work with SMT to decide which countries will be approached.Develop a study wide feasibility questionnaire, selecting vendors and evaluating scope of work/budget.Closeout- work with CSMs to close sites, work with vendors to transfer data, work on CSR with study team.Produce and distribute status, tracking and financial reports for the core project team, other functional groups and senior management.Conduct frequent team meetings and ensure regular communication.All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIESGood knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesProven ability to work through others to deliver results to the appropriate quality and timeline metricsProven ability to understand customer needs and appropriately influence decision makingEffective mentoring and training skillsAbility to balance operational and strategic prioritiesStrong communication and interpersonal skills, including good command of English languageEffective presentation skillsDemonstrated proficiency in using systems and technology to achieve work objectivesDemonstrated proficiency at analyzing data and information to make conclusions and drive sound decision makingMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's degree in a health care or other scientific discipline with 5 years clinical research/monitoring experience; or equivalent combination of education, training and experience.PHYSICAL REQUIREMENTSExtensive use of telephone and face-to-face communication requiring accurate perception of speechExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of timeOccasional travel requirementAt IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible --- to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000 employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA---s Talent Acquisition team at workday_recruitingiqvia.com to arrange for such an accommodation. Full time

Keywords: IQVIA, Somerville , Global Clinical Study Manager, Executive , Somerville, Massachusetts

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