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A leading company in clinical research is seeking a Site Start-up Manager to oversee personnel and project delivery. This role involves mentoring staff, ensuring compliance with high-quality standards, and managing resource allocation. Candidates should have a Bachelor’s degree and at least 6 years of relevant experience in clinical research. Strong leadership and people management skills, along with proficiency in clinical software, are essential for this role.
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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, with an emphasis on 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.
Other Required: People management skills, teamwork, resource management, proficiency with Microsoft Office and clinical software (CTMS, eTMF, EDC), strong communication, organizational skills, and strategic planning experience. Fluency in English.
Preferred: Advanced degree, CRO experience, and additional competencies in leadership, strategic planning, and client interaction.