Senior Clinical Trial Manager – FSP

Yesterday

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Parexel

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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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team. • Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials. • Provide direction and leadership in CRO and vendor selection and management. • Knowledge of regulatory start up process and planning in support of study start up. • Managing and maintaining high performing clinical teams. • Coordination of global clinical trials. • Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct. • Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence. • Be responsible for and manage clinical research activity of Clinical Operations team. • Estimate, track and critically analyze vendor financial spend on study. • Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs. • Provide guidance, direction, and management to site monitoring activity. • Coordinate patient enrollment activities and mitigation planning. • Coordinate study supplies with regulatory and clinical supplies functions. • Negotiate contracts with vendors of clinical trial services. • Review Informed Consent Forms, CRFs, and study related materials. • Plan and participate in investigator meetings. • Assist and support data query process. • Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines. • Ensures trial master file is current and maintained.

🎯 Requirements

• Bachelor’s, nursing degree or equivalent required, science preferred. • 5 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO). • Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device). • Proven experience of clinical trial management. • Experience in CNS and / or oncology is preferred. • Proven management/leadership of people in a matrixed environment. • Management of global clinical trials. • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations. • Demonstrated ability to work independently and in a team environment. • Travel required. Must be willing to travel 15-25%, including international travel. • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook). • Excellent oral and written communication skills and strong organisational abilities.

🏖️ Benefits

• health insurance • retirement plans • paid time off • flexible work arrangements • professional development