Clinical Operations

Responsibilities: 

• Overseeing the planning, implementation, and management of clinical trials, ensuring that they are conducted in compliance with regulatory and ethical guidelines 
• Developing study protocols, case report forms, and other study-related documents in collaboration with cross-functional teams 
• Identifying and managing vendors, including contract research organizations (CROs), clinical laboratories, and other service providers 
• Monitoring study progress, including patient enrollment, data collection, and analysis 
• Ensuring timely data entry and query resolution, and managing data cleaning and database lock activities 
• Managing study budgets and timelines, and ensuring that study costs are within budget 
• Maintaining strong relationships with key stakeholders, including investigators, study coordinators, and regulatory authorities 
• Participating in the preparation of regulatory submissions and inspections 
• Providing guidance and mentorship to clinical operations staff as needed 

Qualifications: 

• Bachelor's or advanced degree in a life sciences field 
• Minimum of [insert number of years] years of experience in clinical trial management or related field 
• Knowledge of ICH-GCP guidelines and other regulatory requirements for clinical trials 
• Strong project management skills, including the ability to manage timelines, budgets, and resources effectively 
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders 
• Strong analytical skills, with the ability to analyze complex data sets and draw insights 
• Ability to work independently and take initiative to resolve issues and ensure timely study execution