Study Start-Up Specialist

Employer Industry: Biotechnology and Pharmaceutical Research

• Salary up to $97,800 annually
• Eligibility for an annual bonus plan for non-commercial roles and an incentive compensation plan for commercial roles
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
• Opportunity to own shares of the employer's stock through discretionary equity awards and participation in the Employee Stock Purchase Plan
• Work in a collaborative and innovative environment focused on fighting cancer
• Chance to contribute to the improvement of clinical trial processes and infrastructure across the Americas

• Support the delivery of study start-up and ongoing submissions within established timelines and quality standards
• Drive the kick-off and completion of tasks from selection through activation of clinical sites
• Manage document preparation and submission to central IRB for timely reviews
• Assist in the collection and review of essential documents while maintaining CTMS data entry
• Contribute to the development of local workflows to streamline output and enhance deliverables

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred
• Minimum of 3 years of progressive experience in clinical research and clinical operations
• Knowledge of ICH/GCP and relevant country regulations/guidelines
• Strong written and verbal communication skills
• Highly organized with the ability to prioritize tasks effectively

• Experience in the biotech, pharmaceutical sector, CRO, or clinical site environment
• Diligence in follow-through and ability to work collaboratively in a team setting
• Demonstrated initiative and an entrepreneurial mindset
• Familiarity with Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams

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