Medical Monitor

4 weeks ago

Bengaluru, Karnataka, India George Clinical Full time
About the Role

The Medical Monitor is a key member of our global clinical trials team, responsible for providing medical and academic input to various aspects of George Clinical studies. This role ensures project delivery is of high quality, operationally aligned, cost-effective, and competitive clinical studies and academic research projects.

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.
Responsibilities

The Medical Monitor will be responsible for:

  • Providing clinical input into the development and/or review of study protocols, procedure manuals, data collection tools, and data quality plans.
  • Reviewing query reports generated from project databases to identify errors and inconsistencies, as outlined in the medical monitoring plan.
  • Providing 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.
  • Developing and providing protocol training from a medical perspective for project investigators and CRAs for the assigned projects, as required.
  • Providing input into ongoing training and education materials for project investigators e.g. study newsletters.
Requirements

To be successful in this role, you will need:

  • 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.
What We Offer

We are a global team making a difference in the world – our clinical trials improve the health of millions worldwide. We offer a competitive salary and benefits, flexible and agile working arrangements, and a focus on employee wellbeing.

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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