Medical Manager

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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

• Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor • Participate actively in study planning with feasibility leaders, solution consultants, and other medical representatives • Provide training of study teams on TA indication and protocol • Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study • Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), Medical Data Review Plan (MDRP) design and implementation • Deliver medical monitoring activities according to MMP during the study conduct • Attend and support any audits or inspections pertaining to assigned studies • Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events • Function as pharmacovigilance representative/safety scientist.

🎯 Requirements

• Experience in clinical medicine (general or specialist qualifications) • At least 3 years of medical monitoring or medical data review experience • Expertise in clinical aspects of drug development, including medical data review and/or Medical Monitoring and study design/execution • Knowledge of drug development processes including drug safety • Well versed knowledge of GCP, ICH, FDA, EMEA and other relevant guidelines. • Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship)

🏖️ Benefits

• Competitive salary • Medical Monitoring Delivery & PV Support • Business Development Support • Client Relationship Building & Engagement