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A leading company is seeking a Site Start-up Manager to oversee personnel and ensure compliance with standard operating procedures in clinical research. This role focuses on personnel development, project delivery, and coordination with cross-functional teams, requiring a strong background in life sciences and extensive site start-up experience.
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Manages and oversees the day-to-day activities of Site Start-up (SSU) personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans. Emphasizes effective resourcing and personnel development. Provides oversight and leadership for site start-up project delivery; coordinates inter-departmental and client communication; and helps resolve administrative, personnel, and project issues.
Minimum Required: Bachelor's degree in life sciences or related field, or equivalent experience. At least 6 years in clinical research with extensive Site Start-up experience. Leadership experience or proven competencies. Knowledge of GCP/ICH guidelines and clinical development process.
Other Required: People management skills, team collaboration experience, proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC), strong communication and organizational skills, strategic planning, risk and change management, fluency in English.
Preferred: Advanced degree in life sciences, CRO experience, and demonstrated leadership competencies.
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