Regional Clinical Trial Management Associate

4 semanas atrás

São Paulo, Brasil BeOne Medicines Tempo inteiro

Regional Clinical Trial Management Associate

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Language Requirement: Fluent English and Spanish is a differentiator. Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology. Location: This is a hybrid position with a minimum of 1 day per week in office in Sao Paulo.

General Description
  • Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budget.
  • Supports the Clinical Research Associates and/or Study Start-up Specialists in country study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards.
  • Builds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager.
  • Supports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager.
  • Might participate in internal working groups, initiatives.
  • Performs other tasks assigned by the line manager.
Essential Functions
  • Develops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.
  • Develops country study management experience by supporting CRAs and SSUSs with multiple aspects of clinical trial conduct including CTMS updates, ISF binder preparation, document collections, ICF customization, eTMF maintenance.
  • Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines.
  • Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings.
  • Establishes good collaboration with key stakeholders regionally, globally and at country level.
Minimum Requirements – Education And Experience
  • Bachelor’s Degree, preferably in a scientific or healthcare discipline required.
  • Higher Degree preferred.
  • 1 or more years of experience in clinical research within biotech, pharma or CRO industry.
  • Fluency in English.
  • Spanish is a differentiator.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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