IRT Vendor Start-up Manager – FSP

🔥 4 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker 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

• Provide technical expertise for the category throughout start-up to close out • Support implementation of defined category strategies and service standardization • Ensure compliance through the life of the studies assigned • Proactively assess risk and conclude contingency plans to de-risk study start-up • Review of the IRT vendor and category related specific sections of the protocol • Contribute to development of Study Specification Worksheet (SSW) • Ensure all submission documents are provided by vendor to countries participating in a study • Support for program overview by providing study demands to VCE • Ensure changes to country and site plans are consistently shared with vendors and VCE • Document issues identified with vendor oversight / performance • Drive root cause analysis of supplier performance issues • Collaborate across sponsor’s departments to provide data for vendor qualification efforts • Review and approve invoices against activity

🎯 Requirements

• 3+ years working experience • Very strong IRT vendor management skills • Excellent knowledge of clinical operation processes and IRT vendor management • Excellent knowledge of GxP and ICH regulations • Expert knowledge of clinical trial design and mapping to supplier requirements • Demonstrated root cause analysis, problem solving, and solution generation skills. • Bachelor's degree in science or business required, with equivalent experience.

🏖️ Benefits

• Health insurance • Flexible working hours • Professional development opportunities