Buenos Aires, Argentina | Full time | Home-based | R
JOB SUMMARY :
Responsible for medical data review and medical safety case processing and related safety activities. Performs review of medical data to ensure medical/scientific plausibility and to employ medical assessment and knowledge. Also, provides medical expertise in assigned trials and standalone safety projects. Train and mentor team members in medical and safety review activities.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES :

-
- Attend and present Medical Data Review activities during the client Kick Off Meeting\
- Write Medical Data Review Plan in collaboration with the Medical Monitor and in accordance with the client input\
- Create protocol specific Medical Data Review Guide in collaboration with the Medical Monitor\
- Participate in the internal eCRF review meeting and contribute to the development of eCRF\
- Define data capture requirements as required throughout the study that are consistent with the protocol and reporting needs\
- Contribute to the Data Review Plan\




- Provide requirements and specifications for programming of data listings\
- Collaborate with Clinical Science and Data Operations teams in the development of Qlik Sense builds and protocol specific customizations for patient profiles\
- Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures\
- Provide medical review of data listings and patient profiles, including but not limited to, adverse events, concomitant medications, medical history, labs, vitals, ECGs, eligibility criteria, efficacy assessments and study specific assessments\
- Prepare protocol specific templates for the periodic summary reports for safety data, including the Safety Trend Analysis Report (STAR) or Safety Review Committee slide presentations, in collaboration with the Medical Monitor\
- Compose the STAR report during the study according to scope and timelines\
- Conduc

📌 Senior Medical Data and Safety Review Physician (Buenos Aires)
🏢 Sercanto
📍 Buenos Aires