(Senior) Study Start-up Specialist
On-siteBasel, Basel-City, Switzerland
Job Summary
Lead the delivery of study start-up, maintenance, and closeout activities, including initial and ongoing submissions, within established timelines and in accordance with ICH/GCP, BeiGene SOPs, and local regulations. Prepare and execute study submission packages for IRB/IEC, regulatory authorities, and institutions while negotiating site contracts and budgets. Engage sites during feasibility to execute CDAs, collect key identification data, and drive kick-off tasks from selection through activation. Build therapeutic area knowledge to provide strategic site recommendations, implement best practices, and proactively resolve issues. Complete and maintain company systems including CTMS and eTMF, mentor junior staff, and actively contribute to process improvement initiatives. Requires a Bachelor's degree with at least two years of similar experience, fluency in English and local languages, and up to 10% travel.
Required Qualifications
- Bachelor's degree or higher in a scientific or healthcare discipline
- At least 2 years experience in a similar role
- Fluent in local language/s as well as written and verbal English
- Strong interpersonal skills
- can do attitude
- problem-solving skills
- Able to multi-task and meet compressed timelines
- Knowledge in the execution of clinical trials
- understanding of ICH/GCP
- Prioritization of tasks in the achievement of goals
- Highly organized
- Diligence in follow through
- Intermediate skills in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams, SharePoint
- Other Computer Skills
Desired Qualifications
- Experience may discretionarily substitute for degree
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