Remote Latam Bi & Data Solutions Manager

Humania Rrhh; Quilmes; Remoto; ARS 139.086.000 - 185.448.000; Tempo pieno

Descrizione del lavoro

Humania Rrhh is seeking a Medical Data Review Manager for a home-based, global scope position focused on rheumatology data review in a multinational clinical trial setting.

The role requires a medical degree with rheumatology specialization and 5+ years in clinical research, including PI/Sub-I experience; you will validate data consistency, protocol adherence, and safety signals while coordinating with the team across sites and meetings.

Competenze

• Bachelor's Degree in Medicine, graduated and specialized in Rehumatology (mandatory)
• 5 years of related experience in clinical research - research site level or CRO/Pharmaceutical companies
• Experience as Sub-Investigator or Principal Investigator (expected)

Mansioni

• Review structured clinical patient data to ensure medical plausibility and adherence to protocol
• Evaluate inclusion/exclusion criteria to confirm patient eligibility for trials
• Review dosing records for protocol adherence and detect inaccuracies or missed dosages
• Assess adverse events, concomitant medications, and medical history for consistency with protocol expectations
• Ensure end-of-treatment and end-of-study information is correctly documented
• Review laboratory results for completeness and safety signals
• Coordinate with medical review staff and participate in kick-off and team meetings

Formazione

Bachelor's Degree in Medicine

Specialization in Rehumatology

Descrizione del lavoro

Medical Data Review Manager Rheumatology

Buenos Aires, Argentina
São Paulo, Brazil
Full time
R

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