Local Study Manager - Remote

December 21, 2024

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Parexel

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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.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Manageable sites, manageable protocols. • Expect exciting professional challenges in inspiring studies, but with time for your outside life. • Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. • Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports. • Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations. • Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.

🎯 Requirements

• Ideally an advanced degree - BSc, MSc or PhD • Minimum of 3 years' experience running local clinical trials. • Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality. • Experience in, and willingness to monitor oncology clinical trials - if needed based on flexible capacity. • Experience performing submissions to RA and EC • Experience partnering with study functions to ensure smooth delivery. • Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.