Medical Monitor

Job Overview

The?Medical Monitor?is a responsible member of a clinical team dedicated to the development and execution of the clinical and operational implementation of?clinical trials.?The?Medical Monitor?provides active medical contribution to?the?cross-functional clinical team. ?The?Medical Monitor?develops the?medical monitoring and safety management plans and conducts?trainings for site staff and study staff for?the?protocol.? The Medical Monitor will?liaise?with clinical trial sites to support?eligibility and protocol related questions.? The medical monitor will also be responsible for **performing ongoing medical data review.??**

Essential Functions

**Participate in?cross functional trial team meetings and?Medical Monitoring?focused?meetings?**

**Responsible for creation, review?and maintenance of?study level plans such as medical?review?plan and safety management plan.?**

**Perform medical review and provide summary of?data review,?safety reporting?and trending?analysis?according to medical monitoring plan?and relevant SOPs.?**

**Review?adverse events for relationship to treatment.? Review SAEs and support related document creation such as SUSAR/PLS, LL?**

Review data for medical correctness, clarity, and consistency.??Review?all data required for events/lab abnormalities.? Query data as needed.? Write draft narratives?for CSR as required **.?**

**Establish relationships with clinical trial sites to discuss protocol questions and enrolment challenges?**

Support development of training materials?for?and perform training

Contribute to clinical development plans, trial protocols and takes?support development?of clinical study reports?as required **for specific trial?**

Plan?and?organize and?support?Eligibility and Data Adjudication Meetings?as required **per protocol?**

**Maintain?close interactions with?Clinical?Scientists and Physicians across programs?**

Assists?the SRP for?Regulatory Affairs in determining **requirements for any corrective actions or health authority reporting??**

Reviews medical literature and related **new technologies?**

May be asked to assess medical publications emerging **from the Team and its affiliates??**

Qualifications

MD (or equivalent) in relevant area with appropriate post- **doctoral training and?board?certification.???**

Specific experience in TA area?or indications?may be required **(i.e.?experience in Immunology related?indications).??**

3+ years experience **?in the pharmaceutical industry conducting clinical trials.??**

Strong working knowledge of ICH-GCP, company standard operating procedures, local laws **and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.?**

Strong IT skills in appropriate software **and company systems.??**

**Willingness to travel with overnight stay away from home according to business needs.??**

**Proficient in speaking and writing in English.?Effective communication skills, oral and written.??**

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at ~~~

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. ~~~

IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. ~~~

The potential base pay range for this role, when annualized, is $186,200.00 - $345,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled