Study Start Up Specialist - (Netherlands Home based) - IQVIA Biotech

Employer
IQVIA Biotech
Location
Netherlands home based
Salary
On Application
Closing date
29 Jun 2019

View more

Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Permanent
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IQVIA Biotech is looking for an experienced Clinical Study Start-up professional in the Netherlands to join our Study Start-Up Group. This is a relatively new group which is growing rapidly.

 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 the Netherlands.

 

.This is a permanent, full time, home based role.

 

  • 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.

 

Candidates must have good prior experience of Study Start Up in the Netherlands and be resident there.

 

Key words: Study Start Up Specialist, study start up, SSU, SSU Specialist, Netherlands

 

IQVIA Biotech is the global, enterprise-wide solution that provides flexible, tailored, integrated clinical and commercial solutions to small biotech and pharmaceutical companies, from planning through trial design and implementation to launch and commercialization.

We recognize that the needs of small companies are different than large companies, so we developed a separate business unit within IQVIA which provides a high-touch solution with high levels of service and hands-on attention, with the benefits of IQVIA’s data and expertise – including powerful analytics, resources, therapeutic experts and global footprint.

IQVIA Biotech has five therapeutic divisions. Complementing our successful history in Oncology, we have dedicated delivery teams in General Medicine – which includes Dermatology, Cardiovascular/Renal/Metabolics, Central Nervous System and Immunology.

Interested in being a part of this exciting and dynamic team?

Contact us today to find out more!

 

Contact Us
  • Ground Floor
  • Abel Smith House
  • Stevenage
  • SG1 2ST
  • GB
  • +44(0)1438 221122
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