17812-Assoc Reg & Start-Up Mgr (R1113635) in Durham, NC at IQVIA™

Date Posted: 2/20/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    2/20/2020
  • Job ID:
    R1113635

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.

The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.

• Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.

• Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.

• Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.

• Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.

• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

• Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.

• Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.

• Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence. Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Work with Quality Management to ensure appropriate quality standards for the duration of the start up.

• Mentor and coach colleagues as required and provide technical guidance both within and outside the project.

• Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.

• May take a proactive role in developing long standing relationships with preferred IQVIA customers.

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: R1113635