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 pr

📌 Clinical Research Manager (India)
🏢 CHETAN MEDITECH PRIVATE
📍 India