The Associate Clinical Operations Leader (CTS) is responsible for study management of assigned projects to drive on-time delivery of clinical trial milestones.

KeyAccountabilities:

Oversight of Project Cycle

• Leading and supporting clinical trials end to end, start up through closeout activities
• Performs study oversight to ensure regulatory and study requirements are being fulfilled
• Maintains thorough understanding of current monitoring practices
• Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools
• Reviews study records including case report forms, consent forms, and other materials
• Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans
• Provides quality and timely study documentation, including trip reports, tracking, and site/sponsor communications in accordance with standard operating procedures
• Maintains accurate and timely sponsor/site communication and correspondence
• Responsible for ensuring Investigational Medicinal Product (IMP) and supplies accountability

Collaborative Relationships

• Develops and maintains collaborative relationships with investigational sites, study teams, Contract Research Organization (CRO) teams, and vendor teams
• Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols

Compliance of Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately and timely as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Knowledge and expertise to review and evaluate medical data
• Well-versed in remote monitoring approaches
• Excellent written and verbal communication, problem-solving, and interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• Ability to travel (minimal travel required)
• Proficient in Microsoft Office Suite (Excel, Word, and PowerPoint), familiar with Microsoft Project
• Proficiency in written and spoken English required
• Proficiency in local language as applicable

Knowledge and Experience:

• 3 years oversight of clinical trials in SSU through closeout in a CRO/pharma capacity, including site management or equivalent

Education:

• Bachelor of Science (BS)/Bachelor of Arts (BA) degree required, degree in healthcare scientific field preferred