Study Operations Lead (R1104213) in Wayne, PA at IQVIA™

Date Posted: 11/20/2019

Job Snapshot

  • Employee Type:
  • Location:
    Wayne, PA
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

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.

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Job Summary

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

Supervisory Responsibilities

This position does not have any supervisory responsibilities.

Experience Requirements

  • 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

Skill Requirements

  • 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
  • Occasional travel

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledWe know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

Join Us

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 to arrange for such an accommodation.

Job ID: R1104213