Associate Clinical Operations Leader (CTS) - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Summary:

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

Key Accountabilities:

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

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.