Clinical Research Manager

CHETAN MEDITECH PRIVATE LIMITED · Gujarat, 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