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Study Start-Up Specialist (Germany, homebased) - Novella Clinical (R1044372) in Frankfurt, DE at IQVIA™

Date Posted: 1/4/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Frankfurt, DE
  • Experience:
    Not Specified
  • Date Posted:
    1/4/2019
  • Job ID:
    R1044372

Job Description

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.

Novella Clinical, a Quintiles company,  is looking for an experienced Clinical Study Start-up professional in Germany to join our new Study Start-Up Unit. The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document collection and review, ICF customization, EC and CA submissions, preparation and negotiation of Clinical Site Contracts for Germany.

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  • 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 Novella. 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 Novella’s business.
  • Facilitates process improvement efforts both within the department and in cooperation with other departments.

We 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™



Job ID: R1044372