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A leading company in precision medicine is seeking a Site Start-up (SSU) Manager to oversee and mentor personnel while ensuring compliance with regulatory guidelines. This role requires at least six years of clinical research experience, along with strong leadership and communication skills. The successful candidate will manage team development, resource allocation, and administrative compliance.
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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 and knowledge of GCP/ICH guidelines.
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 management, and fluency in English.
Preferred: Advanced degree in life sciences, CRO experience, and demonstrated leadership and influence skills.
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