Medical Data Review Manager

IQVIA; Buenos Aires; Presencial; ARS 1.674.000 - 2.902.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Medical Data Review Manager based remotely with a global scope. The role requires a physician specialist in Rehumatology and extensive clinical research experience to validate patient data for protocol adherence and quality, coordinating with other medical review staff.

The position emphasizes ensuring data completeness, medical plausibility, and readiness for next review, with strong English communication and leadership capabilities across multiple projects.

Formación

• Advanced English level with strong communication skills.
• 5 years of related experience in clinical research at site, CRO, or pharma.
• Understanding of clinical/medical data related to clinical trials.
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology.
• Excellent motivational, influencing and coaching skills.

Responsabilidades

• Identify anomalies in patient data requiring further investigation with the clinical site.
• Review inclusion and exclusion criteria to ensure eligibility for the trial.
• Review investigation product dosing records for adherence to protocol.
• Review all reported Adverse Events (AEs), Concomitant Medication and medical history for consistency with protocol.
• Ensure end-of-treatment (EOT) and end-of-study (EOS) documentation is complete.
• Review laboratory results for completeness and protocol adherence.
• Assess any other information to determine readiness of patient information for next review.
• Interact with Medical review staff to verify information and triage data issues.
• Attend Kick-Off meetings, weekly team meetings, and client meetings as needed.

Conocimientos

Advanced English

Clinical research experience

Medical data understanding

Coaching & mentoring

Educación

Bachelor's Degree in Medicine, specialized in Rehumatology

Descripción del empleo

We are looking for a Medical Data Review Manager to join our team!

• Home based - global scope position.
• Specialization in Rehumatology (certified - mandatory).

Job Overview

Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.

Essential Functions

• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy.
• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial.
• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages.
• Review all reported Adverse Events (AEs) , Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
• Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial.
• Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient.
• Review any other information as necessary to determine overall readiness of the patient information for next level review.
• Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Qualifications

• Bachelor's Degree in Medicine, graduated and specialized in Rehumatology (mandatory - we can only consider physicians for this role).
• 5 years of related experience in clinical research - research site level or CRO/Pharmaceutical companies. Experience as Sub-Investigator or Principal Investigator are relevant.
• Advanced English level - great communication skills in the language. The role has a global scope.
• Understanding of clinical/medical data related to clinical trials.
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology.
• Excellent motivational, influencing and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• Strong customer focus skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.