Medical Monitor

2 weeks ago


Bangalore, 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 experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe. Full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trials. We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide. Why work with us? We are a global team making a difference in the world – our clinical trials improve the health of millions worldwide. Competitive salary and benefits Flexible and agile working arrangements - onsite, hybrid, or WFH (dependent on location) Strong and diverse Learning & Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn from A focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events About the role: The Medical Monitor is responsible for providing medical and academic input to various aspects of George Clinical studies. The Medical Monitor ensures project delivery is of high quality, operationally aligned, cost-effective, and competitive clinical studies and academic research projects. This will involve decision-making and roles in cross-functional teams. The Medical Monitor will make every effort to ensure projects are conducted in accordance with Good Clinical Practice and George Clinical standard operating procedures. Key Accountabilities: Provide medical and academic expertise for new and existing George Clinical studies. Support Endpoint Adjudication and other relevant Committees where required. Provide medical input to safety and endpoints documents and to project plans and documents as required. Represent George Clinical and its values with academic colleagues, commercial customers, vendors, government, and regulatory bodies as requested. Participate in team meetings and activities as required. Ensure activities comply with relevant Acts, legal demands, and ethical standards. Project development, initiation, and support Provide clinical input into the development and/or review of study protocols, procedure manuals, data collection tools, and data quality plans; Review query reports generated from project databases to identify errors and inconsistencies, as outlined in the medical monitoring plan. Provide ongoing, continuous support to the sites by taking and answering queries related to medical issues around patient eligibility, recruitment, treatment and management and adverse events, etc. as outlined in the scope of the medical monitoring plan. Develop and provide protocol training from a medical perspective for project investigators and CRAs for the assigned projects, as required. Provide input into ongoing training and education materials for project investigators e.g. study newsletters. Endpoint adjudication activities Liaise with project teams, data management, endpoint coordinators, investigators, site staff, sponsors, and endpoint adjudicators as needed. Provide clinical input into the development of endpoint adjudication manuals, plans, charters, tracking tools, and associated documentation. Provide medical review and input to endpoint packages as required. Safety activities Liaise with internal and external stakeholders as appropriate. Provide clinical input to development of safety manuals, plans, charters, tracking tools, and associated documentation. Where contracted, review and provide narratives for Serious Adverse Events reported on George Clinical trials according to timelines described in the project plans. Provide medical advice and guidance for George Clinical Safety team. In collaboration with line manager, contribute to the development and provision of therapeutic area training for George Clinical staff regularly. Review literature and participate in conducting research that relates to the direct activities or interests of The George Institute and George Clinical. Skills, Knowledge, and Experience: Tertiary qualifications in medicine Experience and expertise in clinical research. Understanding of academic research Working knowledge of current ICH/GCP, ethical, and regulatory requirements Highly developed interpersonal, relationship-building, and negotiation skills. Excellent communication skills including verbal, written, and presentation skills. Ability to travel domestically and internationally. Technological proficiency including Microsoft Office packages. Ability to see the big picture, yet still focus on detail and quality of work. Ability to be flexible and adaptable in changing organizational priorities and ambiguous environments. We are searching for individuals who are excited by the idea of regional and global projects and teams, don’t want to get lost in a large CRO and are ready to have their ideas heard You will be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence. How do I apply and what if I'm interested in a role in future or want to refer someone? Apply via LinkedIn or send your CV, referral or confidential query to careers@georgeclinical.com and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we'll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted. How do I learn more about the roles and George Clinical? Follow us on Linkedin to see our regular updates and how we celebrate our people and success across our business and projects You can also visit us at We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted. Thank you for your interest in working with George Clinical. As a global business, we are committed to handling Personal Information in accordance with applicable privacy and data protection laws in the many countries in which we do business. Please see our Privacy Policy for further information.


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    2 weeks ago


    Bangalore, 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...

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    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...

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