Medical Reviewer-Clinical Data Management

About IQVIA

IQVIA is a leading global company which  provides clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. IQVIA creates intelligent connections in order to accelerate the development and commercialisation of innovative medical treatments.IQVIA also contributes in improving  patient outcomes and population health worldwide.

Role Overview

A Medical Review Specialist within the Clinical Data Management team, is a professional who  uses his clinical expertise to review and validate structured patient data across  all the clinical trials. The reviewer  ensures that the medical accuracy, protocol compliance, and data quality is maintained  thoroughly by working closely with clinical study teams, sponsors, and internal stakeholders.

This is one of the strongest roles in the  non-clinical career path for medical professionals who like science and want to  contribute to global drug development from a perspective of operation and strategy.

Key Responsibilities

• Review structured patient data to identify anomalies, inconsistencies, and protocol deviations, to  ensure that the medical congruency and clinical plausibility is maintained  at every level of the project and the there is no mistake in the whole project.

• Use your  clinical knowledge in order  to validate data against therapeutic area, indication, and study population expectations.

• With minimal guidance you have to solely provide project management support to clinical study teams which  includes workload planning, issue escalation, and process improvement.

• Your clinical knowledge is very vital because you will Serve as Subject Matter Expert (SME) on medical data review practices and quality standards.

• As a customer oriented company you need to maintain  strong client relationships and ensure that there is  a high level of customer satisfaction throughout the project lifecycle.

•  You will track service performance metrics to identify root causes of issues, and implement remedial actions in collaboration with leadership to contribute in the process of improvement.

• You need to be  diligent and ensure timely follow-up and resolution of compliance-related issues which are harming the improvement of the company.

• As a Subject Matter Expert you need to provide therapeutic area and indication training to project clinical teams.

• You need to always identify opportunities to improve task efficiency and quality of deliverables.

• Attending the Kick-Off meetings, weekly team meetings, and client meetings as required are also one the most important aspects of the role.

Required Qualifications

• Your MBBS degree  or an equivalent medical degree; or other medical qualification with a 5-year college degree is applicable.

• Having a Bachelor's degree in a clinical or biological discipline with a minimum of 3 years of experience in clinical practice or clinical research is a must.

• Having a demonstrated experience in clinical data sciences at a CRO, pharmaceutical company, or related medical environment is necessary and can make your application significant.

• Proven leadership experience within a clinical or data management setting.

• Equivalent combination of education, skills, and experience will be considered in lieu of formal degree requirements.

Preferred Qualifications

• Understanding of  clinical trial processes, with knowledge of GCP guidelines, and structured data review methodologies make you better.

• As a Medical Review Specialist experience with electronic data capture (EDC) systems or clinical data management platforms is going to be really helpful in day-to-day working.

• Having an exposure to oncology, rare disease, or other complex therapeutic areas can help you to review and lead the team and can make your decision making efficient.

Skills & Competencies

• In your job the most crucial thing is reviewing and so having a good understanding of clinical and medical data makes it a necessary skill to have.

• When communicating with the clinical research team knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology make your communication better and also makes your understanding better if there is any kind of problem.

•  You will be making sure about the medical accuracy , compliance and protocols and so having strong operational focus   and the ability to work with metrics to take appropriate actions is a necessary skill.

• The job role requires you to communicate with many people on a daily basis in order to maintain relations and so excellent communication, interpersonal skills, customer service, and teamwork skills is a must.

• Leading various teams in your job expects you to have excellent organisational and problem-solving skills.

• Strong project management and coaching skills are necessary because each project needs to be completed within the set deadline with the standard compliance guidelines and  with proper medical accuracy.

• In the job you are going to act as a bridge between various teams or departments and so because of this intersection having the ability to establish and maintain effective working relationships with coworkers, managers, and clients is crucial.

Benefits

•  The company offers you a meaningful non-clinical career track that makes  your medical background work in global clinical research.

•  The role will give an exposure to international clinical trials across multiple therapeutic areas giving you an experience which would be very beneficial in your career to grow further.

•  The company offers you health benefits, and if you work really hard they also provide performance-based incentives, and in order to grow in  your career further they also provide learning and development support.

• You will get a flexible hybrid work arrangement at the Bengaluru office. The company has an  inclusive culture that values integrity, diversity within the company and always thinks about continuous professional growth of each and every employee which works in the company.

Integrity Notice

As a global leading company which provides so many services to clients worldwide IQVIA maintains a zero-tolerance policy for candidate fraud and so  all the  information submitted during the application process needs to  be truthful and complete and if there is any false statements, misrepresentations, or material omissions  this will result in immediate disqualification during the application process or termination of employment if discovered later, in accordance with applicable law.