Senior Study Start-up Specialist

Há 4 dias

Sao Paulo, Brasil BeiGene Tempo inteiro

Company Overview:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients

General Description:

- Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.

Essential Functions:

- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Site Feasibility

o Build knowledge in therapeutic area, local regulations and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.
- Site Start-Up

o Skilled in driving kick-off and completion of tasks from selection through activation.

o Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.

o Prepare submissions dossiers to Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs and work instructions.

o Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
- ICF/Submissions

o Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.

o Skilled in document preparation and submission to central IRB to ensure timely reviews.
- Support review of essential documents
- Provide Regulatory support after approvals, including submission of core documents to the sites and Regulatory Authority. Supply Regulatory Authority with Annual/Final reports.
- Complete SSU data entry in CTMS, if applicable
- Support in the development of local workflows to streamline output and deliverables.
- Contribute to the ongoing improvement of SSU infrastructure in the Americas - in the U.S., Canada, and Latin America
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals.
- Support vendors qualification until final setup in LATAM. May act as point of contact with vendors for issues/alignment.
- Perform the translation process for ethical and regulatory documents.

Minimum Requirements - Education and Experience:

- Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

Other Qualifications:

- Knowledge in the execution of clinical trials, understanding of ICH/GCP
- Effective prioritization of tasks in the achievement of goals
- Strong written and verbal communication skills
- Highly organized
- Diligence in follow through

Supervisory Responsibilities: NA

Travel: Up to 10%

Computer Skills:

- Intermediate skills in Microsoft Office - Outlook, Word, Excel, PowerPoint, Teams

add #LI-Remote

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- 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

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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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