Senior Clinical Research Specialist

Overview

• Serve as a Senior Clinical Research Specialist, contributing to groundbreaking medical device research and development initiatives in a remote contract-based role.
• Lead clinical trial operations, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.
• Collaborate with cross-functional teams to optimize processes and resolve trial management challenges effectively.
• Author protocols and manage patient record forms to support impactful clinical evaluation research studies.
• Engage with senior stakeholders to influence decision-making and achieve project objectives.
• Utilize advanced clinical research expertise to deliver meaningful outcomes and drive innovation.
• Contribute to site and vendor selection, clinical supply operations, and budget management for trials.
• Support a collaborative environment focused on advancing healthcare solutions through clinical research excellence.

Key Responsibilities & Duties

• Design and implement clinical evaluation research studies for innovative medical devices.
• Prepare detailed protocols and patient record forms to ensure trial accuracy.
• Conduct both registered and non-registered clinical studies addressing medical and commercial needs.
• Analyze clinical investigation results for potential applications in healthcare solutions.
• Ensure adherence to GCP, SOPs, and country-specific regulations throughout trial processes.
• Provide mentorship and guidance to colleagues, fostering professional development and collaboration.
• Manage project timelines, budgets, and operational aspects effectively.
• Recommend and implement process improvements to enhance research efficiency and outcomes.

Job Requirements

• Bachelor of Science degree required; advanced degree preferred.
• Minimum of 4 years of experience in clinical research or trial management.
• Proficiency in CTMS, EDC, and TMF systems; strong knowledge of GCP regulations.
• Experience in driving clinical trial timelines and managing operational aspects.
• Preferred knowledge of diabetes therapy and audit processes.
• Excellent communication skills for engaging with stakeholders and influencing decisions.
• Ability to work independently while mentoring and collaborating with colleagues.
• Practical knowledge of project management and process optimization techniques.