International CRO is looking for graduates in health sciences, preferably medicine, with experience in clinical research, preferably in oncology, with team working skills. Medical monitor is oriented to international projects. Comfortable work environment.
Medical Monitor will work with a cross-functional team to ensure the medical/clinical integrity and quality of clinical studies. This individual will ensure studies are conducted in compliance with the protocol, standard operating procedures, all applicable competent authority regulations and international Good Clinical Practices (GCP).
This role will serve as the medical monitor contact in study protocols to investigators and study sites team regarding protocol compliance issues and safety of the subjects enrolled.
The Medical Monitor will advise and assure investigators and project teams on safety issues arising from investigational medicinal products. The Medical Monitor role will review SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and ICH E2 reporting standards.
Responsibilities (including, but not limited to):
- Oversee the safety aspects of assigned clinical trials; including adverse events, safety reporting and laboratory testing in consultation with the project manager.
- When appropriate, assists the development lead in discussions on safety issues or concerns that may have arisen. Engage with clinical team to answer eligibility and other medical related questions associated with clinical trials.
- Prepare the SAE and Safety Reporting section of the Project Plans.
- Oversees the processing of SAEs, SUSARs, etc. to regulatory agencies.
- Serve as the medical monitor contact in study protocols.
- Provide Medical reviews of SAE information.
- Evaluate protocol deviations.
- Provide Medical Monitor coverage for international clinical trials.
- Review and address all medical alerts in assigned studies.
- Review clinical laboratory data on selected studies for safety tends or signals.
- Assist clinical data management with MedDRA and WHO DD coding.
- Conduct the medical reviews of safety listings and clinical trial data in assigned studies.
- Assist by reviewing or writing safety section of a clinical trial report and other safety reports including post marketing reports (e.g. PSUR).
- Assist in the set up and conduct of Data Safety bodies (DSMB, DMB or similar) as required.
- Assist with protocol interpretation and, as needed, contact others to ensure appropriateness of decisions arising from such interpretation.
- Attend and participate in investigators’ meeting and other committees’ meetings as requested.
- MD Degree with a minimum 3 years experience in clinical research.
- Able to independently make medical decisions for the study and can act as primary Medical Monitor on studies.
- High level of interpersonal and presentation skills Knowledge of MedDRA and WHODrug coding and terminology.
- Strong attention to detail and excellent organization skills.
- Strong interpersonal skills and communication skills (both written and oral).
Send a cover letter and your CV to: email@example.com