Clinical Research Manager

CHETAN MEDITECH PRIVATE LIMITED · Ahmedabad, India

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