Clinical Study Operations Manager - must have experience in managing studies in the Netherlands

Pharmiweb
Stuttgart
EUR 60.000 - 80.000
Jobbeschreibung

Title - Clinical Study Operations Manager

Location: Can be based in the UK, Spain, Italy, or Germany.

Must have experience in managing studies in the Netherlands.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Working fully embedded within an ever-expanding program, the Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention).

You will be accountable for the execution of tasks of moderate complexity and developing solutions to problems as needed to support deliverables:

  1. Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned).
  2. Regional/Country/Study level Recruitment Strategy.
  3. Responsible to support the development of study level plans.
  4. Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans.
  5. Responsible for study and/or country vendor management and oversight including follow-up and coordination of vendor deliverables.
  6. Responsible for ensuring the follow-up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.

The Study Operational Manager will be able to work independently and exercise their own judgement.

In order to be successful in this role, you must have:

  • BA/BS
  • 5+ years of relevant experience
  • MBA/MS with 3+ years of relevant experience
  • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
  • Full right to work in the UK

Although you'll be based in the UK, you'll be covering the Netherlands as a market, so you must have experience in managing studies in the Netherlands.

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