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Observational Research Specialist II

Poland, Remote Additional Locations: Amsterdam, North Holland, Netherlands; Belgrade, Serbia; Bucharest, Bucureşti, Romania; Budapest, Budapest, Hungary; Prague, Czechia; Wavre, Walloon Brabant, Belgium; Zagreb, Croatia Job ID R0000022111 Category Clinical Trials
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About this Role

We are currently looking for an Observational Research Specialist II to join the team in EMEA. You must be a fluent German speaker and be based in one of the following countries:

  • Croatia - Any Region - Home Based

  • Czech Republic - Any Region - Home Based

  • Poland - Any Region - Home Based

  • Hungary - Any Region - Home Based

  • Romania - Any Region - Home Based

  • Serbia - Any Region - Home Based

  • Netherlands - Any Region - Home Based

  • Belgium - Any Region - Home Based

Some travel to Germany will be required.

In this role you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations. Responsible for supporting the development of the Clinical Operations service delivery within Parexel.

 Key Accountabilities:

  • Depending on study assignment and with support as necessary key accountabilities can include:

    • Primary contact for assigned sites and build positive business relationships with physicians and site staff.

    • Site identification, selection and start-up activities including negotiation of site agreements and budgets.

    • Customization of country/site specific documentation.

    • Conduct of all remote and on-site monitoring activities through all study stages.

    • Identification of potential out of scope activities.

    • Perform regular reviews of data according to Site Management Plan (SMP).

    • Responsible for the completeness and quality of the site files for the assigned sites.

    • Maintain study management system(s) on a daily basis.

  • Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices (GPP) guidelines, local country requirements, SOPs and study specific procedures.

  • Contribution to department service delivery and participation in initiatives.

Knowledge and Experience:

  • Strong experience with Observational/ Non-interventional research studies.

  • Able to manage study from FEAS to Close out (including Ethics Committee submission and CSA negotiation)

  • Must be a fluent German speaker.


  • Degree in a life science, nursing qualification or other relevant experience required.


  • Excellent interpersonal, verbal and written communication skills.

  • Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including GPP.

  • Ability to work in a 'virtual' team environment as well as work independently, seeking guidance as appropriate.

  • Ability to manage complex workload (across multiple studies as necessary) and prioritize accordingly.

  • Consistently delivers work to 'First Time Quality' whilst managing time effectively to meet metrics and/or team objectives.

  • Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines.

  • Willing to travel internationally as necessary.

  • Effectively applies knowledge to provide advice or solutions based on expertise and experience.

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