• About the Role
  This position is responsible for ensuring the successful, timely, and quality execution of start-up and maintenance activities for assigned sites and studies. The role involves establishing country/site activation plans, assessing risks, and implementing mitigation strategies in collaboration with various teams. The candidate will proactively identify and communicate issues impacting delivery and propose solutions.
  
  Responsibilities
• Ensure timely and quality execution of start-up and maintenance activities for assigned sites and studies.
• Establish country/site activation plans and priorities, including risk assessment and mitigation plans.
• Attend regional/area start-up calls and provide input for assigned sites/studies.
• Collect essential documents from sites and complete quality checks.
• Compile and submit ethics and other required local document packages, including customization of ICFs and patient-facing materials.
• Coordinate with Regulatory and CTS on CA submission and approval status.
• Collaborate with contract managers and other team members to ensure timely site activation.
• Manage clinical supply shipments and site activation processes.
• Maintain local country and site intelligence databases and performance metrics.
• Provide start-up updates and metrics to relevant leads.
• Ensure compliance with corporate policies and worldwide regulations.
• Participate in process improvement initiatives.
• Train and mentor new specialists in country start-up processes.
  
  Education Qualification
• Bachelor's Degree in healthcare or a scientific field is highly preferred, or equivalent years of experience required.
  
  Required Skills
• A minimum of 3-5 years of clinical research experience, with at least 1+ years in study start-up management.
• Experience working with remote or virtual teams.
• Strong interpersonal skills with the ability to build trust and communicate effectively.
• Ability to adapt to changing requirements and manage multiple priorities in a fast-paced environment.
• Working knowledge of ICH and Good Clinical Practice guidelines and an understanding of the country's regulatory environment.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range:- $50/hr to $60/hr