Senior Clinical Research Specialist

Overview

• Serve as a Senior Clinical Research Specialist, driving clinical trial timelines and ensuring compliance with regulatory standards.
• Conduct clinical evaluation research studies, author protocols, and manage patient record forms effectively.
• Oversee operational aspects of clinical trials, ensuring adherence to Good Clinical Practice (GCP) and standard operating procedures.
• Collaborate with project teams to resolve trial management issues and optimize processes.
• Work remotely, contributing to innovative medical device research and development initiatives.
• Utilize advanced education and experience to deliver impactful clinical research outcomes.
• Engage with senior internal and external stakeholders to influence decision-making and achieve project objectives.
• Manage clinical supply operations, site and vendor selection, and trial budgets.

Key Responsibilities & Duties

• Design, plan, and develop clinical evaluation research studies for medical devices.
• Prepare and author protocols and patient record forms for clinical trials.
• Conduct registered and non-registered clinical studies to address medical needs and commercial potential.
• Interpret results of clinical investigations for new drug, device, or consumer applications.
• Resolve operational aspects of clinical trials in collaboration with project teams.
• Ensure compliance with GCP, SOPs, and country-specific regulations.
• Provide guidance and coaching to colleagues, managing projects and delegating tasks.
• Analyze and recommend improvements to processes, systems, or products.

Job Requirements

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