Senior Clinical Trial Manager

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 external vendors and contract research organizations • Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual • Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents • Assist with protocol development and study report completion • Manage monitoring activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols • Provide guidance, direction, and management to CRAs • Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities • Coordinate study supplies • 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 • Ensure trial master file is current and maintained • Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials

🎯 Requirements

• Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans) • Strong experience in clinical trials management (at least 6 years) • Strong experience of data management and query resolution in clinical trials • Overall knowledge of site management and monitoring procedures • Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines) • Degree in the life sciences field preferred

🏖️ Benefits

• Exceptional financial rewards • Training and development • Healthy work-life balance