Senior Study Start-up Specialist ( Home/Office Based) - IQVIA Biotech (R1084177) in Morrisville, NC at IQVIA™

Date Posted: 7/18/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    7/18/2019
  • Job ID:
    R1084177

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.

IQVIA Biotech is now hiring for a Senior Study Start-up Specialist. Must have 3+ years of Start up experience.

TITLE:                            Study Start-Up (SSU) Specialist

REPORTS TO:              Manager Level – SSU

BASIC FUNCTIONS:

Under general supervision from the SSU manager, will conduct and facilitate specific start-up activities that may include site identification, feasibility, essential document collection and review, ICF customization, EC submissions, preparation and negotiation of Clinical Site Contracts for site locations in one of the following countries: Italy, United Kingdom, Spain, Germany, France or Belgium.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.
  • Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
  • Review and provide feedback to SSU manager on site performance metrics.
  • Work with regulatory team members and SSU manager to secure authorization of regulatory documents.
  • Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned country.
  • Responsible for the translation and co-ordination of translations for documents required for submission.
  • Responsible for liaising with local CRA/CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.
  • Work with legal team members and SSU Manager to secure authorization of contracts.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • May participate in feasibility and/or site identification activities.
  • Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
  • Collects and reviews initial regulatory packets and site contracts for investigator sites.
  • Assures that SSU functions interface effectively with all other key operating departments within IQVIA Biotech. Working with Clinical Operations, Project Management, Site Identification, additional SSU specialists, Regulatory and Contracts group on SSU project specific status and deliverables.
  • Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
  • Create, review and customization of country/site specific Informed Consent Forms (ICFs).
  • Participates in business development activities to grow IQVIA Biotech’s business.
  • Facilitates process improvement efforts both within the department and in cooperation with other departments.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated knowledge of quality assurance related to study startup.
  • Ethics submission experience for assigned country (Italy, United Kingdom, Spain, Germany, France or Belgium).
  • Regulatory submission experience for assigned country (Italy, United Kingdom, Spain, Germany, France or Belgium).
  • Organize local regulatory submissions within assigned country (Italy, United Kingdom, Spain, Germany, France or Belgium).
  • Demonstrated ability to form strong working relationships across functional boundaries.
  • Excellent written and verbal communication skills.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Ability to manage multiple projects.
  • Demonstrated knowledge of resources required to permit protocol implementation.
  • Considerable ability to develop and maintain productive relationships with coworkers, managers and clients.
  • Ability and willingness to travel.

MINIMUM RECRUITMENT STANDARDS:

  • MA/MS in a health-related field with at least 4 years of demonstrated clinical trials experience; and or BS /BA/BSc in a health-related field with relevant of demonstrated clinical trials experience; and or appropriate BA/BS/BSc or equivalent discipline. Within the total years of experience, at least three (3) years of management experience in a contract clinical research position is required. 
  • Pharmaceutical clinical research experience required.
  • Knowledge of electronic data management and issues affecting study start up. Excellent written and verbal communication skills are required
  • Fluent in language of assigned country (Italy, United Kingdom, Spain, Germany, France or Belgium).

CRITICAL JOB FUNCTIONS:

  • Ability to travel
  • Very limited physical effort required to perform normal job duties

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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: R1084177