Senior Clinical Research Manager

4 days ago

new delhi, India Endovision Full time
Company Description
Endovision helps improve the diagnostic accuracy of upper GI endoscopists by leveraging the power of deep learning and computational modeling and aid the doctors by providing real-time deep video analytics solutions. By enhancing efficiency, Endovision aims to facilitate better healthcare outcomes.
Position Overview
The Clinical Research Manager will play a pivotal role in planning and executing the collection of clinical evidence essential for product development and regulatory approvals. This role will be responsible for developing procedures and methodologies for clinical evaluations of our SaMD products and ensuring seamless integration into clinical practice. The ideal candidate will have experience in clinical research and validation studies, with a background in the medical device industry.
Key Responsibilities:
Clinical Study Planning and Execution:
Develop and oversee the execution of clinical research strategies to support product development and regulatory submissions.
Design and implement clinical studies, including protocol development, site selection, and investigator training.
Ensure compliance with all regulatory requirements and guidelines (e.g., FDA, EU, ISO) during clinical studies.
Data Collection and Analysis:
Supervise the collection, management, and analysis of clinical data to generate robust evidence supporting the safety and efficacy of our SaMD products.
Collaborate data analysis and statistical sampling activities to ensure accurate and meaningful data interpretation.
Regulatory Submissions:
Prepare and review clinical study protocols, reports and other associated regulatory documentation for submissions to regulatory authorities.
Liaise with regulatory bodies and respond to queries related to clinical evidence and study outcomes.
Cross-Functional Collaboration:
Work closely with Product Development and Regulatory Affairs teams to align clinical research activities with business objectives.
Provide clinical insights and feedback to inform product development and refinement.
Monitor study progress, identify and rectify problems, and present progress reports internally.
Clinical Practice Integration:
Develop and implement strategies for the integration of our SaMD products into clinical practice.
Support healthcare providers in adopting and utilizing our AI-based solutions.
Quality and Compliance:
Ensure all clinical research activities are conducted in accordance with Good Clinical Practice (GCP) and other relevant standards.
Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices in clinical research.
Qualifications:
Bachelor’s degree in a relevant field (e.g., Life Sciences, Biomedical Engineering).
5-10 years of experience in clinical research within the medical device industry.
Strong communication and interpersonal skills, with the ability to collaborate effectively across disciplines and with external partners.
Fluent with spoken and written English, and reading comprehension.
Proven track record of designing and managing clinical studies, including experience with regulatory submissions and interactions.
Strong understanding of clinical trial methodologies, regulatory requirements, and data analysis techniques.
Experience with project management, with the ability to manage multiple studies and priorities simultaneously.

  • Senior Clinical Research Associate

    4 weeks ago

    Delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Senior Clinical Research Associate

    2 weeks ago

    Delhi, Delhi, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Business Development Manager-Clinical Services and Pharma

    1 month ago

    delhi, India MS CLINICAL RESEARCH Full time

    Job Title : Business Development Manager-Clinical Services and PharmaLocation : BengaluruCompany : MS Clinical Research Pvt LtdAbout Us:MS Clinical Research Pvt Ltd is a leading organization in the clinical research industry, providing comprehensive clinical services to the pharmaceutical sector. We are committed to advancing scientific knowledge and...

  • Senior Clinical Research Associate

    4 weeks ago

    delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Senior Clinical Research Associate

    1 month ago

    delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Senior Clinical Research Associate

    2 weeks ago

    Delhi, Delhi, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Senior Clinical Research Associate

    2 weeks ago

    Delhi, Delhi, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Senior Clinical Research Associate

    2 weeks ago

    Delhi, Delhi, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...

  • Senior Clinical Research Manager

    4 days ago

    New Delhi, India Endovision Full time

    Company DescriptionEndovision helps improve the diagnostic accuracy of upper GI endoscopists by leveraging the power of deep learning and computational modeling and aid the doctors by providing real-time deep video analytics solutions. By enhancing efficiency, Endovision aims to facilitate better healthcare outcomes.Position OverviewThe Clinical Research...

  • Senior Clinical Research Manager

    4 days ago

    new delhi, India Endovision Full time

    Company Description Endovision helps improve the diagnostic accuracy of upper GI endoscopists by leveraging the power of deep learning and computational modeling and aid the doctors by providing real-time deep video analytics solutions. By enhancing efficiency, Endovision aims to facilitate better healthcare outcomes. Position Overview The Clinical...

  • Senior Clinical Research Manager

    4 days ago

    New Delhi, India Endovision Full time

    Company DescriptionEndovision helps improve the diagnostic accuracy of upper GI endoscopists by leveraging the power of deep learning and computational modeling and aid the doctors by providing real-time deep video analytics solutions. By enhancing efficiency, Endovision aims to facilitate better healthcare outcomes.Position OverviewThe Clinical Research...

  • Senior Clinical Research Manager

    4 days ago

    New Delhi, India Endovision Full time

    Company DescriptionEndovision helps improve the diagnostic accuracy of upper GI endoscopists by leveraging the power of deep learning and computational modeling and aid the doctors by providing real-time deep video analytics solutions. By enhancing efficiency, Endovision aims to facilitate better healthcare outcomes.Position OverviewThe Clinical Research...

  • Clinical Research Associate

    4 days ago

    Delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Research Associate

    11 hours ago

    Delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • ▷ [15h Left] Clinical Research Associate - all levels

    4 days ago

    Delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?- A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence- 20+ years of...

  • Clinical Data Manager

    2 months ago

    delhi, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Research Coordinator

    4 weeks ago

    Delhi, Delhi, India Apollo Research and Innovation Full time

    Position - Clinical Research Coordinator Experience - **Fresher not eligible** Above 1 Years (Experience in Clinical Research ) Timing - General Shift Qualification - D.Pharm/B.Pharm/ Pharm D Salary - CTC 2.50 L per annum (based on your experience it may differ) Contract Period - Minimum 2 Years (No Bond) Location - Delhi Language Knows -...

  • Clinical Research Associate

    4 weeks ago

    New Delhi, India ICON Strategic Solutions Full time

    We are hiring for CRAII and Senior CRAs across India.ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Responsibilities: Site MonitoringSIV ~ COVPI...

  • Clinical Research Associate

    3 weeks ago

    New Delhi, India ICON plc Full time

    As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include: Full ownership of investigator sites for...

  • Head of Clinical Research development

    2 weeks ago

    Delhi, Delhi, India Venus Remedies Limited Full time

    Head - Clinical Research DepartmentQualification:An MBBS graduate with professional experience of min 10 years in the fieldThe Lead Scientist of Clinical Research will provide oversight, leadership, and guidance in the management and execution of clinical research. He/She will work collaboratively with the executives to establish research priorities and...