Observational Research Specialist II

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.

Education:

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

Skills:

• 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.