Medical Monitor

Medical Monitor

We are seeking a medically qualified professional to provide clinical and scientific oversight throughout the clinical trial lifecycle, with a strong focus on participant safety, data integrity, and regulatory compliance. In this role, you will work closely with investigators, sponsors, and cross-functional clinical research teams to support the safe and effective execution of clinical studies. You will assess safety events, interpret clinical data, contribute to study design, and help ensure adherence to established protocols and international guidelines. The position combines medical expertise, scientific analysis, and stakeholder collaboration in a global, remote working environment. This is an opportunity to influence clinical research quality, strengthen patient protection, and contribute to the development of healthcare solutions.

Accountabilities

• Provide medical monitoring for clinical trials, safeguarding participant well-being and ensuring appropriate medical oversight throughout each study.
• Review and assess adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), ensuring timely escalation, documentation, and regulatory reporting.
• Support adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, study protocols, and applicable local regulatory requirements.
• Contribute to protocol development, investigator meetings, study start-up activities, and regulatory submissions.
• Provide medical input into study design, feasibility assessments, risk management, and protocol development to ensure scientific rigor and participant safety.
• Contribute to the preparation and review of Clinical Study Reports, investigator brochures, informed consent forms, training materials, and other regulatory documentation.
• Review clinical trial data, identify safety trends, and provide medical assessments that support informed decisions throughout study execution.
• Act as a key medical contact for investigators and clinical sites, responding to protocol-related questions and safety concerns while coordinating with sponsors and internal clinical teams.
• Participate in safety review meetings, Data Monitoring Committee meetings, and investigator meetings as required.
• Identify and mitigate medical risks, support audit and inspection readiness, and contribute to the continuous improvement of medical monitoring processes and best practices.

Requirements

• Medical degree or equivalent qualification in medicine.
• Clinical experience in a hospital or comparable healthcare setting.
• Previous medical research experience in a clinical research organization (CRO), pharmaceutical company, hospital, or regulatory body.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements governing clinical trials.
• Demonstrated ability to evaluate clinical trial data, assess safety trends, and make sound medical decisions.
• Understanding of clinical research methodologies, clinical study design, and relevant statistical concepts.
• Experience reviewing clinical protocols, clinical data, study reports, and other scientific or regulatory documentation.
• Scientific writing experience and the ability to contribute to high-quality clinical and regulatory documents.
• Knowledge of medical monitoring practices, patient safety oversight, adverse event assessment, and safety reporting procedures.
• Strong analytical and critical-thinking skills, with sound judgment and attention to detail.
• Excellent written and verbal communication skills and the ability to collaborate effectively with multidisciplinary teams.
• Strong organizational and problem-solving skills, with the ability to manage documentation accurately and address challenges in clinical trial execution.
• Adaptability and flexibility when working in a dynamic, fast-paced, international environment.
• Fluency in English.
• Ability to work remotely and collaborate effectively across teams and time zones.

Benefits

• Competitive salary range: The advertised annual salary range is USD 120,000250,000, with the final offer determined by work location, relevant experience, skills, qualifications, internal equity, and role scope. The applicable range for Brazil should be confirmed during recruitment.
• Remote work: Remote working arrangement, subject to the applicable location and employment terms.
• Professional development: Opportunities to develop expertise and advance professionally in clinical research and healthcare.
• Flexible work programs: Access to flexible working arrangements, subject to role and location.
• Global collaboration: Opportunities to work with international colleagues across clinical, scientific, and healthcare disciplines.
• International exposure: Potential opportunities for global collaboration and travel, depending on business needs and role requirements.