clinical operation manager

Key Responsibilities1.Clinical Trial ManagementLead and manage all aspects of clinical trial operations in Philadelphia, including study start-up, patient recruitment, data collection, and monitoring.Develop and implement clinical trial plans, timelines, and budgets in accordance with company standards and regulatory requirements.Ensure compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable local and international regulations.Collaborate with clinical research sites, investigators, and sponsors to ensure the smooth conduct of clinical trials.2.Team Leadership and ManagementBuild, lead, and mentor a high-performing clinical operations team in Philadelphia, providing guidance, support, and performance feedback.Foster a culture of collaboration, innovation, and continuous improvement within the team.Allocate resources effectively to ensure the timely and successful completion of clinical trials.Oversee the training and development of team members to enhance their skills and knowledge in clinical operations.3.Cross-functional CollaborationWork closely with cross-functional teams, including clinical development, data management, biostatistics, regulatory affairs, and medical affairs, to ensure seamless communication and coordination throughout the clinical trial process.Participate in cross-functional meetings, provide updates on clinical trial progress, and contribute to the development of strategies and solutions to address challenges.Collaborate with international teams to align clinical trial operations with global strategies and requirements.Qualifications and Requirements1.EducationBachelor's degree in life sciences, medicine, pharmacy, or a related field; a master's degree or higher is preferred.2.Work ExperienceMinimum of 8 - 10 years of experience in clinical operations within the pharmaceutical or biotechnology industry, with at least 3 - 5 years in a leadership role.Proven track record of successfully managing clinical trials from start to finish, including experience in all phases of clinical development.Experience working in a global clinical operations environment, with exposure to international clinical trial regulations and standards.3.Skills and AbilitiesStrong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.Excellent leadership and team management skills, with the ability to motivate and inspire team members to achieve high performance.Proficiency in English and Chinese, both written and verbal, with the ability to communicate effectively in a multicultural environment.In-depth knowledge of clinical research regulations, GCP, SOPs, and industry best practices.Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software tools.

Created: 2025-06-03