Study Operations Lead (R1034626) in Wayne, PA at IQVIA™

Date Posted: 9/11/2018

Job Snapshot

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

Job Description

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

Job ID: R1034626