ApplyContract - Senior Study Startup Specialist (SSUS)
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💎 Seniority level: Senior, 8+ years of related experience
📍 Location: United States
💸 Salary: 80.0 - 100.0 USD per hour
🔍 Industry: Biopharmaceutical
🏢 Company: Cytokinetics👥 251-500💰 $550,000,000 Post-IPO Equity 9 months agoBiotechnologyBiopharmaHealth Care
⏳ Experience: 8+ years of related experience
🪄 Skills: Project ManagementData AnalysisComplianceBudgetingStakeholder management
Requirements:
- University Degree or equivalent, preferably in a medical/science-related field.
- 8+ years of related experience.
- Demonstrated knowledge of clinical trials and project management.
- Knowledge of ICH guidelines.
Responsibilities:
- Update knowledge on regulatory requirements and ensure compliance.
- Execute all start-up activities prior to site activation on assigned studies.
- Prepare Informed Consent Forms and obtain necessary approvals.
- Analyze study start-up data for efficiency and opportunities for improvement.
- Partner with Clinical Trial Managers on regulatory requirements and site activations.
- Support drug label preparation for studies as required.
- Collaborate with authorities to enhance clinical trial processes.
- Collaborate with CTMs on new investigator sites and patient recruitment.
- Responsible for study budget and contracts negotiation.
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