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A leading company in the clinical research field seeks a Site Start-up Manager to oversee daily operations and personnel development. The role requires extensive Site Start-up experience, leadership skills, and a strong understanding of regulatory guidelines. Candidates should possess a Bachelor's degree in life sciences and have excellent communication, strategic planning, and people management skills. This position offers a great opportunity for career development and the chance to lead a dedicated team.
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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; 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, team collaboration, resource management, 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, CRO experience, and demonstrated leadership competencies such as strategic thinking, influence, negotiation, and conflict management. Ability to inspire excellence, foster ownership, and lead teams effectively. Strong presentation and interpersonal skills. Willingness to travel occasionally.
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