Country Study Manager

Romania, Bucharest

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Who we are

As a research-focused healthcare company, Roche discovers, develops and provides innovative diagnostics and therapeutic products and services that deliver significant benefits to patients and healthcare professionals - from early detection and prevention of diseases to diagnostics, treatment and treatment monitoring. Roche is a successful company that can offer exciting career opportunities. We encourage and support your development in areas of your interest which will prepare you for the next level in your career path. We know that people are responsible for our success and we value our employees.

We’re looking for a Country Study Manager to join Roche Romania Pharma who will ensure the effective and efficient delivery of studies operational aspects through all phases of study management.

Main responsibilities:

  • Contributes in developing, leading and maintaining strategic and budget activities, throughout the phases of studies.
  • Ensures the effective delivery of operational aspects in all phases of study management (feasibility, site selection, initiation, conduct, close-out), in accordance with the plans.
  • Has full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget.
  • Provides oversight, leadership and support to CRO staff (i.e. Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, and cost) and interfaces regularly with local Roche Vendor Manager and CRO Management regarding feedback on CRO staff performance.
  • Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality and cost).
  • Calculates study budgets and discuss it with sites.
  • Ensures compliance to Fair Market Value (FMV) in the country.
  • Liaises with HCO to implement budget cost containment and implements contingencies as required.
  • Proactive contribution to study start-up and patient recruitment strategies, and to activities in ensuring efficient trial management

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You, as an ideal candidate, will have the following skills, experience and education:

Education

  • University Degree in Medical Sciences (Medicine/ Biology)

Experience

  • At least 3 years of experience in the Pharmaceutical industry, in Romanian market,  in clinical studies activities
  • One year as project leader in clinical studies will be an advantage
  • Advanced knowledge of English, both written and spoken; native in Romanian language
  • Good knowledge of Microsoft Office suite: Word, Excel and PowerPoint

Key competences

  • Organizational and time management skills: can priorities multiple tasks and goals to ensure timely and high-quality accomplishment, can work simultaneous with multiple deadlines.
  • Team worker as well as individual player, problem solver, self-initiative
  • Ability to work collaboratively and effectively in a fast moving work environment
  • Strong written and verbal communication skills

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Development