Medical Device Clinical Trial Consultant

Job Overview:We are seeking a highly motivated Clinical Trial Consultant to lead and drive forward our clinical trials for wearable device technology. This role will require strategic oversight, decision-making, and hands-on involvement to ensure clinical trials proceed smoothly and efficiently. The ideal candidate will work closely with data consultants, engineers, and clinical teams, assessing real-time data to make informed adjustments to trial protocols and device performance as needed. This position is critical to aligning clinical and technical efforts, and it offers an opportunity to play a key role in the advancement of our technology.Key Responsibilities:Clinical Trial Leadership: Act as the primary driver of clinical trial execution, working with cross-functional teams to ensure all aspects of the trial are advancing effectively and in compliance with regulatory standards.Data Oversight and Evaluation: Collaborate with data consultants and engineers to receive, analyze, and validate incoming trial data. Provide actionable insights and implement adjustments to the trial process as required.Strategic Decision-Making: Take a proactive role in decision-making throughout the trial lifecycle, assessing data trends and making real-time adjustments to optimize trial outcomes and device performance.Collaboration with Engineering: Partner closely with engineering teams to address technical issues and integrate necessary changes in response to clinical trial findings, ensuring device accuracy, reliability, and functionality.Vendor and Contractor Supervision: Oversee third-party contractors and other external resources, ensuring their contributions align with project goals, timelines, and quality standards.Regulatory Compliance: Manage regulatory requirements for trial data collection and submission, working to ensure the trial is in compliance with FDA regulations, ISO 13485, and other applicable medical standards.Technical Guidance: Provide technical input to support the engineering and data analysis teams, helping bridge clinical needs with engineering solutions.Qualifications:Education: Bachelor's or Master's degree in Biomedical Engineering, Clinical Research, or a related field.Experience: 5+ years of experience in clinical trials within the medical device industry, ideally with wearable technologies or remote patient monitoring.Leadership and Decision-Making: Proven experience in a decision-making role for clinical trials or related projects, with the ability to make data-driven choices and lead teams effectively.Data and Analytical Skills: Strong ability to interpret clinical data, assess data accuracy, and make adjustments to clinical protocols or device settings.Regulatory Expertise: Solid knowledge of FDA regulations and clinical trial protocols, with experience in regulatory submissions such as 510(k) for medical munication: Excellent interpersonal skills to communicate effectively with both technical and non-technical stakeholders, ensuring alignment across all involved teams.Problem-Solving: Demonstrated ability to resolve complex issues in real-time and adapt to challenges that may arise during clinical trials.Notes:Location: Hybrid role based in the Philadelphia area. Onsite presence required, particularly during initial clinical trial phases.Startup Environment: Candidates should be adaptable and comfortable in a startup setting, taking initiative and wearing multiple hats as needed.Collaborative Role: This role will involve working closely with the CEO and key stakeholders to align clinical and business objectives.

Created: 2024-11-06