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Associate Study Start-Up Manager
Company | BeiGene |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-08-03 |
Posted at | 10 months ago |
BeiGene 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.
- 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.
- Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
- Support in the facilitation of SSU Forum discussions
- Manage resource allocations and support in resource forecasting activities.
- Support in management and maintenance of SSU resources (i.e., SSU Toolbox (Americas))
- Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key information to support with site identification and selection; Liaise with internal stakeholders (i.e., CRAs, FMDs, CSMs) as needed.
- Competent in communication and influencing skills to ensure timely follow-up, issue resolution, and report updates
- Ensure collection and review of essential documents
- Skilled in driving kick-off and completion of tasks from selection through activation.
- ICF/Submissions
- Provide country-specific SSU expertise to project teams
- Demonstrates proficiency of skills required to conduct SSU activities from site identification through activation
- Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.
- Skilled in document preparation and submission to central IRB to ensure timely reviews.
- Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America
- Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Site Feasibility
- Site Start-Up
- Assignment as SSU Lead and back-up support as needed for direct or functional reports’ studies.
- Support in the development of local workflows to streamline output and deliverables
- Ensure completion of SSU data entry in CTMS
- Mentoring and training team members
- Effective prioritization of tasks in the achievement of goals
- Highly organized
- Functional Service Provider model knowledge and/or experience
- Knowledge in the execution of clinical trials, understanding of ICH/GCP
- Diligence in follow through
- Strong written and verbal communication skills
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