Global Clinical Operations Leader – Clinical Trial Manager

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead global clinical operations strategy and execution for assigned clinical trials. • Drive study startup including site selection, monitoring strategy, and operational planning. • Coordinate cross functional teams across geographies ensuring alignment on timelines quality and deliverables. • Monitor study progress including recruitment retention data quality and timelines and take corrective action when needed. • Identify risks early and implement mitigation and contingency plans. • Provide leadership direction and performance feedback to project team members. • Function as primary point of contact for sponsors on clinical operations topics. • Ensure compliance with ICH GCP regulatory requirements and internal processes. • Oversee maintenance and quality of study documentation and central files. • Support audits inspections and study closeout activities including database lock and archiving. • Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture

🎯 Requirements

• Degree in life sciences, nursing, or equivalent clinical research experience • Minimum of 5 years of experience leading clinical operations within a CRO environment • Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader • Experience leading complex global or multi-region studies • Strong knowledge of ICH GCP regulatory requirements and clinical trial processes • Experience coordinating cross functional teams and managing study timelines budgets and quality • Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities