Senior Clinical Research Associate

2 semanas atrás

São Paulo, São Paulo, Brasil BeiGene Tempo inteiro

BeiGene is expanding rapidly, presenting exciting and challenging opportunities for seasoned professionals. We seek individuals who are scientifically and commercially driven, collaborative, and share our deep commitment to combating cancer.

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement : Proficient in English and Portuguese. Spanish is advantageous.

Preferred Experience : Background in Pharmaceutical/Biotech Sector, Hematology, Oncology

Company Overview:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: is a global, commercial-stage, research-focused biotechnology firm dedicated to molecularly targeted and immuno-oncology cancer therapies. With a workforce exceeding 10,000 across various countries, BeiGene is advancing a pipeline of innovative oral small molecules and monoclonal antibodies aimed at cancer treatment. Our mission is to develop combination therapies that have a significant and lasting impact on cancer patients.

General Description:

The Clinical Research Associate (CRA) will take on the role of primary CRA. Responsibilities include conducting site visits (such as PSSV, SIV, IMV, COV) and acting as the site manager. The CRA is tasked with establishing and nurturing relationships with key site personnel while ensuring effective communication. Monitoring data quality and patient safety through site education and oversight is also a critical function. CRAs are expected to complete all aspects of the clinical monitoring process in compliance with ICH-GCP guidelines, local regulations, and relevant SOPs.

Essential Functions:

  • Execute and coordinate designated components of the clinical monitoring process in alignment with GCPs and SOPs to evaluate the safety and efficacy of investigational products and/or medical devices.
  • Conduct site visits to assess compliance with protocols and regulations, and prepare necessary documentation.
  • Cultivate collaborative relationships with investigative sites and study vendors.
  • Provide training on protocols and related studies to assigned clinical study sites.
  • Participate in disease indication and/or project-specific training as required.
  • Maintain oversight of site performance by tracking metrics related to enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site challenges.
  • Act as a mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues.
  • Communicate site performance metrics to the Clinical Study Team (CST).
  • Conduct study-specific training with the project team.
  • Manage Serious Adverse Event (SAE) reconciliation and collaborate with study sites to resolve discrepancies.
  • Work with CST and clinical study sites to ensure timely achievement of study milestones (including study startup, recruitment, database analyses, closeout, etc.).
  • Attend regional investigator meetings and site booster visits as necessary.
  • Provide support for audit/inspection preparation at clinical study sites and ensure that quality issues or findings are addressed promptly.
  • Assist with additional clinical responsibilities within the scope of the role as required.

Minimum Requirements – Education and Experience:

A BS/BA in a relevant scientific field with a minimum of 3+ years of pertinent Clinical Operations experience, including at least 2+ years in monitoring.

Other Qualifications:

  • Comprehensive understanding of clinical trial processes with a solid grasp of ICH and associated regulatory guidelines.
  • Exceptional communication and interpersonal skills.
  • Strong organizational skills with the ability to prioritize and manage multiple tasks.
  • Proficient in English (both written and spoken).

Supervisory Responsibilities:

  • Provide site-level management for established protocols and portfolios under general supervision.
  • Offer mentoring/support to CRAs on CRA-related topics.
  • Co-monitor with CRAs and assist with site visits as needed.

Travel: Up to 70% travel may be required.

Computer Skills:

  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
  • Familiarity with industry CTMS and data management systems.

#LI-Remote

BeiGene Global Competencies:

By embodying our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, we strive to deliver more affordable medicines to patients worldwide through our twelve global competencies:

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

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