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- Execute and coordinate designated elements 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, preparing necessary documentation.
- Foster 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.
- Monitor site performance by tracking metrics related to enrollment, data entry into Case Report Forms (CRFs), protocol deviations, and overall site challenges.
- Serve as a mentor and trainer for less experienced CRAs, assisting with general and study-specific monitoring issues.
- Communicate site performance updates 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 (e.g., study startup, recruitment, database analyses, closeout).
- Attend regional investigator meetings and site booster visits as necessary.
- Provide support for audit/inspection preparation at clinical study sites, ensuring quality issues are addressed promptly.
- Assist with additional clinical responsibilities as required within the scope of the role.
- Comprehensive understanding of clinical trial processes, with in-depth knowledge of ICH and associated regulatory guidelines.
- Exceptional communication and interpersonal skills.
- Strong organizational skills with the ability to prioritize and manage multiple tasks.
- Fluent in English (both written and spoken).
- Provide site-level management for established protocols and portfolios under general supervision.
- Offer mentoring and support to CRAs on CRA-related topics.
- Co-monitor with CRAs and assist with site visits as needed.
- Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
- Familiarity with industry CTMS and data management systems.
- 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
Lead Clinical Operations Associate - São Paulo, Brasil - BeiGene
Descrição
BeiGene is experiencing significant growth, presenting exciting and challenging opportunities for skilled professionals. We seek individuals who are not only scientifically adept but also possess strong business acumen, are highly motivated, and share our fervent commitment to combating cancer.
PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION
Language Requirement : Proficiency in English and Portuguese. Knowledge of Spanish is advantageous.
Preferred Experience : Background in Pharmaceutical/Biotech Industry, with a focus on Hematology and Oncology.
Company Overview:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: ) is a global, research-driven biotechnology firm dedicated to developing molecularly targeted and immuno-oncology therapies for cancer. With a workforce exceeding 10,000 across various countries, including China, the United States, Switzerland, Australia, and Brazil, BeiGene is advancing a robust pipeline of innovative oral small molecules and monoclonal antibodies aimed at transforming cancer treatment. Our mission is to create impactful combination therapies that provide meaningful and lasting benefits to cancer patients.
General Description:
The Clinical Research Associate (CRA) will take on the responsibilities of a primary CRA, conducting site visits (including PSSV, SIV, IMV, COV) and acting as the site manager. The CRA will establish and nurture relationships with key site personnel, ensuring effective communication. Additionally, the CRA will oversee data quality and patient safety through diligent monitoring and site education. All clinical monitoring activities will be performed in compliance with ICH-GCP guidelines, local regulations, and relevant SOPs.
Essential Functions:
Minimum Requirements – Education and Experience:
A BS/BA in a relevant scientific discipline is required, along with a minimum of 3+ years of relevant Clinical Operations experience and at least 2+ years of monitoring experience. Experience in global oncology trials is preferred.
Other Qualifications:
Supervisory Responsibilities:
Travel: Up to 70% travel may be required.
Computer Skills:
#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: