Key Responsibilities

1.Clinical Trial Management

• Lead 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 Management

• Build, 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 Collaboration

• Work 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 Requirements

1.Education

• Bachelor's degree in life sciences, medicine, pharmacy, or a related field; a master's degree or higher is preferred.

2.Work Experience

• Minimum 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 Abilities

• Strong 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.