Clinical Research Manager

Overview

• Manage day-to-day activities for local, regional, and global clinical studies, ensuring adherence to timelines and budgets.
• Oversee Early Access Programs, coordinating cross-functional teams and ensuring compliance with country-specific requirements.
• Collaborate with external consultants, including CROs and clinicians, to ensure project-specific training and deliverables.
• Develop and monitor study budgets, timelines, and resources for successful project execution.
• Ensure quality and compliance in clinical trial management systems and reporting processes.
• Contribute to study planning, setup, and operational assessments for investigator-sponsored trials.
• Provide proactive issue monitoring and solution-oriented management for complex situations.
• Represent the organization in networking with global and local stakeholders.

Key Responsibilities & Duties

• Coordinate clinical trial management, including study plans, timelines, and resource allocation.
• Oversee Early Access Program activities, including supply chain management and medical reviews.
• Manage budgets for local, regional, and global clinical studies and investigator-sponsored trials.
• Ensure compliance with ICH GCP guidelines and local regulatory requirements.
• Monitor clinical trial status in management systems, ensuring accurate tracking and reporting.
• Facilitate cross-functional collaboration for study planning and execution.
• Provide training and oversight for independent consultants involved in clinical trials.
• Develop innovative solutions for complex clinical research challenges.

Job Requirements

• Bachelor of Science (BS) in Medical or Life Sciences or equivalent qualification.
• Minimum of 5 years of experience in clinical research within CRO, pharma, or biotech industries.
• Thorough knowledge of ICH GCP guidelines and clinical trial planning.
• Proficiency in English and local language for effective communication.
• Demonstrated ability to manage multiple tasks and prioritize effectively.
• Experience with Early Access Programs and non-interventional studies preferred.
• Strong analytical skills and proactive problem-solving capabilities.
• Excellent interpersonal, written, and presentation skills.