Clinical Manager

Company Description

TAG Dream is an innovative medical device startup revolutionizing surgical tools to improve patient outcomes and support healthcare professionals. Our cutting-edge technology combines precision engineering and clinical insight to deliver transformative solutions. We seek a driven Clinical Manager to join our fast-growing team and lead our clinical research efforts

Role Description

We seek a highly skilled and experienced Clinical Trials Manager to lead and oversee the planning, execution and management of pre-clinical and clinical studies for our innovative surgical tools. The candidate must have experience managing pre-clinical trials, including animal studies and ex vivo tests, and have a proven record in defining and writing clinical protocols and Clinical reports. This role requires close collaboration with Contract Research Organizations (CROs), laboratories, hospitals, and internal teams to ensure successful trial execution and alignment with regulatory standards.

Key Responsibilities:

• Clinical  and Pre-clinical Trials Management
• Design and execute clinical studies, including preclinical (animal and ex vivo) and clinical trials, to support product development and regulatory submissions.
• Develop study timelines, budgets, and milestones to align with company objectives.
• Collaborate with R&D teams to interpret preclinical results and guide the development of clinical strategies.
• Protocol Development:
• Define and write comprehensive clinical protocols for pre-clinical and clinical studies, aligning with project goals, regulatory requirements, and industry standards.
• Ensure protocols are practical, scientifically robust, and adhere to Good Clinical Practices (GCP).
• CRO and Site Management:
• Identify, evaluate, and manage relationships with CROs, research labs, and clinical sites to ensure project alignment and timely study completion.
• Monitor the performance and quality of external partners, ensuring adherence to study protocols and regulatory guidelines.
• Report Writing and Documentation:
• Prepare detailed reports and summaries of study results for internal R&D use, supporting product development and design iterations.
• Develop submission-ready documents for regulatory authorities, ensuring compliance with medical device regulations (e.g., FDA, MDR).
• Regulatory Compliance:
• Ensure all studies meet applicable medical device regulatory guidelines (e.g., ISO 10993, FDA 21 CFR, MDR).
• Maintain meticulous records and documentation to support regulatory submissions and audits.
• Data Management and Reporting:
• Oversee data collection, ensuring accuracy, consistency, and integrity in alignment with regulatory and company standards.
• Present findings to internal teams, stakeholders, and regulatory bodies as required.
• Cross-functional Collaboration:
• Work closely with R&D, regulatory, and quality teams to ensure clinical insights are integrated into product development.

Qualifications

• Education:
• Bachelor’s, Master’s, or Ph.D. in life sciences, biomedical engineering, pharmacology, or a related field.
• Experience:
• Proven experience managing preclinical trials for medical devices, including animal and ex vivo studies.
• Strong track record in writing clinical protocols, technical reports, and regulatory documentation.
• Experience working with CROs, research laboratories, and hospitals.
• In-depth knowledge of regulatory standards for medical devices (e.g., FDA, ISO, MDR).
• Skills:
• Exceptional technical writing and documentation skills.
• Strong organizational and project management abilities.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects and adapt to a fast-paced, dynamic environment.

Preferred Qualifications:

• Experience with Class II or Class III medical devices, particularly surgical tools.
• Familiarity with ISO 14155 and medical device clinical evaluation guidelines.
• Knowledge of biocompatibility testing standards (ISO 10993).