Responsible for in-house monitoring and program management of phase 1-3 clinical trials.
Responsible for management of vendor materials, regulatory reviews related to conduct of trials, study and patient tracking.
Serves as the project manager for selected projects, and the primary contact for study site personnel.
Assists with the design, development and monitoring of clinical evaluation projects.
Assures adherence to good clinical practice, integrity of the clinical trial data and investigator compliance with all study procedures related to onsite monitoring.
Participates in study development and startup process including: protocol writing, reviewing and revising of case report forms, and development of form completion specifications.
Leads aspects of clinical outsourcing to vendors such as labs, electronic data capture suppliers, and other service providers.
Communicates designs and objectives for clinical trials, delegates workflow to lower level staff, and monitors operational progress.
Presents information on protocols and monitoring procedures to investigators.
Contributes to various regulatory submissions including annual reports.
Assists in the development of clinical standard operating practices.
Coordinates clinical efforts in adverse event recording.
Ensures the pre-study, initiation, routine monitoring, and close down visits of study sites.
Reviews cases with investigators, determines and monitors time schedules, prepares investor packets, and issues status reports.
Provides mentoring and training of lower level clinical trials staff.Calificaciones
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
Minimum of four years of pharmaceutical and/or clinical trial experience, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills.
Team leader experienceUbicación principal
México-Distrito Federal-Ciudad de MéxicoOrganización
Janssen de México, S. de R.L. de C.V. (7250)Área
Clinical Trial AdministrationRequisition ID