IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
The Study Operations Lead is the main point of contact for the sponsor and manages the client relationship, oversees payment management projects and ensures sponsor satisfaction is achieved. The Study Operations Lead manages and oversees the initiation and study management of protocols including identifying all protocol related information, timelines, reporting and initial setup of proprietary software system used to initiate studies.
Summary of Essential Job Functions
Acts as the primary point of contact for assigned sponsor(s) and associated studies
Responsible for managing the project timeline and identify/pursue change orders and coordinating with the contracts management team
Prepares materials and KPi’s for sponsor governance meetings and participates as appropriate
Identify and execute process improvement initiatives when appropriate
Prepares, arranges and executes regular client meetings and ensures all necessary materials are prepared with accuracy and completeness
Function as the engagement leader providing management throughout the length of the clinical trial by overseeing activities of the project team to ensure sponsor commitments and DrugDev’ service levels are achieved.
Coordinates with Site Operations and Data Operations to ensure proper resource assignment and service delivery quality
Ensure that DrugDev financial interests are appropriately protected through diligent scope of work management efforts
Ensure support to the clinical trial sites is provided at DrugDev’ levels of excellence through timely resolution of issues that are raised through email and/or phone contact
Responsible for ensuring that payments do not exceed SOW timelines
Responsible for ensuring change orders are executed and communicated to appropriate personnel
Responsible for performance review input to Site Operations and Data Operations for roles that support assigned sponsor
Coordinates with the Site Operations team members to prepare sponsor funding
Ensure that all DrugDev processes and standards are followed and that appropriate financial controls are observed and are in line with sponsor requirements for managing and mitigating financial risk
Ensures work is SSAE 16 compliant were appropriate
Responsible for monitoring, assist in resolving and escalating operational and performance metric issues
Other duties as assigned
This position does not have any supervisory responsibilities.
Experience as a Site Operations Associate or Data Operations Associate
Bachelor’s Degree in Finance, Business Administration or equivalent experience
Experience with financial business applications preferred
General knowledge of Clinical Trial Industry preferred
Project management or team leadership experience preferred
Must be customer focused and have excellent written and oral communication skills
High energy, self-starter with the ability to work in a team environment as well as independently
Able to think independently, and to analyze and solve problems creatively
Strong time management and planning skills
Knowledge of Clinical Trial Industry
Detail oriented, analytical and the ability to meet aggressive deadlines
Comfortable working in a global company environment
Strong PC skills (i.e. Microsoft Office,Google, MS Project, SAP-Business One)
Familiarity with foreign currency
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer – Minorities/Females/Protected Veterans/Disabled
IQVIA, 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 [email protected] to arrange for such an accommodation.
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