Job Overview :
We are seeking an experienced and strategic Senior Manager of Clinical Research to lead and execute our clinical study programs. This role is pivotal in designing, managing, and delivering high-quality clinical evidence to achieve regulatory approvals (PMDA,CE,FDA), support product commercialization, and contribute to scientific publications. The ideal candidate is a proactive leader with a deep understanding of Good Clinical Practice (GCP), medical device regulations, has worked with CRO in clinical trials execution and has experience in managing clinical trials from concept to closure.
Key Responsibilities
Clinical Strategy & Study Design
- Contribute to the development of the global clinical evidence strategy for new and existing products.
- Lead the design and development of clinical study protocols, case report forms (CRFs), statistical analysis plans (SAP), and other key study documents.
- Conduct feasibility assessments for new clinical programs.
Study Execution & Management
Manage the end-to-end execution of multiple clinical studies, ensuring they are delivered on time, within budget, and in compliance with all regulatory requirements and company SOPs.Select, manage, and oversee Contract Research Organizations (CROs), central labs, and other vendors to ensure high-quality performance.Serve as the primary point of contact for clinical investigators and site staff.Regulatory Compliance & Documentation
Ensure all studies are conducted in accordance with ICH-GCP, ISO 14155, and all applicable global regulations.Manage the preparation and submission of essential documents to IRBs / ECs and regulatory authorities.Manage regulatory agency and notified body inspections on clinical studiesData Management & Analysis
Oversee clinical data management activities to ensure data integrity and quality.Collaborate with biostatistics to analyze and interpret clinical data.Author, review, and finalize clinical study reports (CSRs).Leadership & Cross-Functional Collaboration
Provide leadership, mentorship, and direction to junior clinical team members.Collaborate effectively with internal stakeholders including Corporate Affairs, Investor Relations, R&D, Regulatory Affairs, Quality Assurance, Medical Affairs.Manage the clinical study budget and resources effectively.Present clinical strategy and study updates to senior management.Qualifications & Experience
Bachelor's degree in a Life Science, Nursing, Engineering, or related field. Advanced degree (MS, PhD, MD) highly preferred.Minimum of 5+ years of direct experience in clinical research within the medical device industry (experience with Class II / III devices is essential).Proven experience leading and managing all phases of clinical studies (feasibility, start-up, execution, close-out).Demonstrated success in contributing to regulatory submissions (PMA, 510(k), IDE, EU MDR) and interacting with regulatory agencies (FDA, notified bodies).Deep knowledge of ICH-GCP, ISO 14155, FDA 21 CFR Parts 812, 50, 54, 56, and EU MDR regulations.Strong experience in vendor and CRO management.Excellent written and verbal communication skills, with experience authoring protocols, reportsValid GCP certificate