Role Overview: We are seeking a skilled and experienced Clinical research Manager to lead the clinical study associated activities along with preparing the Clinical Documents efforts for non-active implantable medical devices. This role will also be responsible for guiding the team through design and develop clinical protocols and execute clinical studies (pre-market or post-market studies). The candidate should have extensive experience in clinical evidence generation strategy and scope research topics to provide recommendations on clinical trial strategy. The ideal candidate will bring in-depth knowledge of international medical device clinical research expertise, robust scientific writing capabilities, and demonstrated experience in end-to-end clinical evaluation and evidence generation. Key Responsibilities: Clinical Evidence Development: · Author and maintain high-quality clinical documents including CERs, CEPs, PMCFPs, PMCFRs, PMSP, PSURs, and SSCPs in line with EU MDR and other international standards.
· Conduct thorough risk–benefit analyses and integrate data from preclinical, clinical, and post-market sources. Cross-functional Collaboration: · Interface closely with R&D;, Clinical Affairs, Marketing, and Regulatory teams to access and identify the necessary preclinical, clinical and technical information. · Develop clinical and marketing communication tools such as peer-reviewed manuscripts, white papers, one-pagers, slide decks, surgical techniques, and more. Scientific Literature Research & Analysis: · Design robust and reproducible literature search strategies. · Perform systematic literature reviews and create comprehensive State of the Art summaries across diverse indications and implant technologies. · Critically appraise scientific literature and write clinical summaries to determine evidence gaps, assist in research and development of clinical strategies for clinical investigational protocols. Clinical Study Documentation: · Draft clinical trial pro