Job Description
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.
Job Tags
Full time, Part time, Local area, Night shift,