Role Overview: /n 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. /n /n Key Responsibilities: /n Clinical Evidence Development: /n · 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. /n · Conduct thorough risk–benefit analyses and integrate data from preclinical, clinical, and post-market sources. /n Cross-functional Collaboration: /n · Interface closely with R&D;, Clinical Affairs, Marketing, and Regulatory teams to access and identify the necessary preclinical, clinical and technical information. /n · Develop clinical and marketing communication tools such as peer-reviewed manuscripts, white papers, one-pagers, slide decks, surgical techniques, and more. /n Scientific Literature Research & Analysis: /n · Design robust and reproducible literature search strategies.



/n · Perform systematic literature reviews and create comprehensive State of the Art summaries across diverse indications and implant technologies. /n · Critically appraise scientific literature and write clinical summaries to determine evidence gaps, assist in research and development of clinical strategies for clinical investigational protocols. /n Clinical Study Documentation: /n · Draft clinical trial protocols, ethics approval submissions, case report forms, informed consent documents, investigator brochures, clinical study reports, and support regulatory related submissions. /n · Develop and manage clinical trial documentation: site master files, trial master files, Clinical trial logs, etc. /n Clinical Operations & Oversight: /n · Lead clinical budgeting and financial management, including preparation and negotiation of trial budgets, oversight of vendor contracts and clinical study agreements, management of investigator, and site payments. /n · Oversee aspects of clinical operations, including monitoring visits, generation of reports, and coordination with third-party CROs and sites. /n · Draft clinical study agreements, insurance documents, and ensure operational compliance across trial activities. /n · Initiate,



monitor and close-out clinical studies on study sites in accordance with applicable national and international regulations, MDCGs, guidelines of ICH-GCP and NDCT-2019. /n Regulatory & Compliance Frameworks: /n · Ensure documentation aligns with latest MDR 2017/745 and relevant guidance (e.g., MEDDEV 2.7.1 Rev. 4, MDCGs, ISO 14155:2020, ISO 14971, ICH-GCP, etc.). /n · Interpret and apply risk management standards and post-market surveillance frameworks, contributing to proactive safety strategies. /n · Leading the team of clinical research and guiding Regulatory teams by providing inputs on intended use/clinical clinical research material preparation etc. /n /n Essential Requirements: /n · Domain Expertise: Proven experience in authoring regulatory and clinical documents for non-active implantable medical devices. /n · Regulatory Acumen: Solid understanding of relevant global regulatory frameworks, especially EU MDR, MEDDEV, MDCG guidance documents, ISO standards, and ICH-GCP guidelines. /n /n Core Competencies: /n · Risk–benefit analysis /n · Scientific writing (CER, BER, PMCF, PSUR, SSCP, etc.) /n · Managing and supporting clinical studies/trials on medical devices /n · Clinical trial documentation & project coordination /n · Literature review & data appraisal /n · Cross-functional communication and stakeholder engagement /n /n Required Knowledge of Guidelines and Standards: /n · EU MDR 2017/745 /n · MEDDEV 2.7.1 Rev. 04 /n · MEDDEV 2.12/2 Rev. 2 /n · MEDDEV 2.12/1 /n · MDCG 2020-5/6/7/8 /n · MDCG 2019-9 Rev.1 /n · ISO 14155:2020 /n · ICH-GCP /n · Current Drugs and Clinical Trials Rules, 2019 /n · ISO 10993-1 /n · ISO 14971 /n · ISO 24971

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