Clinical Research Manager

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 protocols, ethics approval submissions, case report forms, informed consent documents, investigator brochures, clinical study reports, and support regulatory related submissions. · Develop and manage clinical trial documentation: site master files, trial master files, Clinical trial logs, etc. Clinical Operations & Oversight: · 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. · Oversee aspects of clinical operations, including monitoring visits, generation of reports, and coordination with third-party CROs and sites. · Draft clinical study agreements, insurance documents, and ensure operational compliance across trial activities. · 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. Regulatory & Compliance Frameworks: · 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.). · Interpret and apply risk management standards and post-market surveillance frameworks, contributing to proactive safety strategies. · Leading the team of clinical research and guiding Regulatory teams by providing inputs on intended use/clinical clinical research material preparation etc. Essential Requirements: · Domain Expertise: Proven experience in authoring regulatory and clinical documents for non-active implantable medical devices. · Regulatory Acumen: Solid understanding of relevant global regulatory frameworks, especially EU MDR, MEDDEV, MDCG guidance documents, ISO standards, and ICH-GCP guidelines. Core Competencies: · Risk–benefit analysis · Scientific writing (CER, BER, PMCF, PSUR, SSCP, etc.) · Managing and supporting clinical studies/trials on medical devices · Clinical trial documentation & project coordination · Literature review & data appraisal · Cross-functional communication and stakeholder engagement Required Knowledge of Guidelines and Standards: · EU MDR 2017/745 · MEDDEV 2.7.1 Rev. 04 · MEDDEV 2.12/2 Rev. 2 · MEDDEV 2.12/1 · MDCG 2020-5/6/7/8 · MDCG 2019-9 Rev.1 · ISO 14155:2020 · ICH-GCP · New Drugs and Clinical Trials Rules, 2019 · ISO 10993-1 · ISO 14971 · ISO 24971