Senior Clinical Research Specialist
4 semanas atrás
BeiGene is seeking a highly skilled Senior Study Start-Up Specialist to join our team. As a key member of our clinical operations team, you will be responsible for delivering study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.
Key Responsibilities:- Site Feasibility: 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: Skilled in driving kick-off and completion of tasks from selection through activation. Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
- ICF/Submissions: Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
- Regulatory Support: Provide Regulatory support after approvals, including submission of core documents to the sites and Regulatory Authority. Supply Regulatory Authority with Annual/Final reports.
- 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.
- 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.
- Opportunity to work with a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
BeiGene is an equal opportunity employer and we value diversity. We do 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.
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