Reg & Start Up Spec 1 (R1103651) in Durham, NC at IQVIA™

Date Posted: 11/1/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    11/1/2019
  • Job ID:
    R1103651

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.

JOB OVERVIEW

Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level.

Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of regulatory and contractual documents for sites; ensures contracts are fully executed; and establishes project timelines. 

Responsibilities

Essential Functions

•Set up and maintain DrugDev Spark for new projects (i.e. checklists, dashboards, reports, and document templates

•Negotiate simple contractual documents with investigator sites (i.e. CDAs) as determined by the Start-Up Lead or Senior Start-Up

      Lead

•Lead site feasibility projects which includes feasibility questionnaire distribution and collection, as well as leading project team

      meetings with clients

•Perform quality control reviews of Essential Site Regulatory Documents via DrugDev Spark

•Upload investigator site documents to client specified locations (i.e. client e-TMF, SharePoint workspace, etc…)

•Serve as primary point of contact for investigator sites, either personally or through a shared mailbox.

•Assist in the preparation for regulatory and/or sponsor audits

Experience

Typically requires 0 - 2 years of prior relevant experience.

Knowledge

Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.

Standard ADA Settings

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Office Environment

The above information on this description has been designed to indicate the general nature and level of work performed.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job.  While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1103651