Centralized Study Asso I

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

Position provides process, control, coordination, and approval of clinical trial documents. Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF). ¨ Maintains an understanding of applicable regulatory requirements. ¨ Managing electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in...

Job Overview Provide project related assistance to assigned project teams.; Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements.; Meeting quality and timeline metrics.; Essential Functions - Complete appropriate role-specific training to perform job duties. -...

Single point of accountability to embed the application of Risk Based Quality Management aligned with the study planning, study protocols, GSK SOPs, ICH GCP and regulatory requirements for assigned GSK sponsored and outsourced studies.; includes the set up and execution of Central Monitoring and Data Analytics tool. Drive discussions with Global Clinical...

ICON is looking for a Central Monitor to be based in Chennai. The Central Monitor is responsible for listing review and central data analysis to support quality and risk reviews of projects, by highlighting/escalating trends. Job Responsibilities As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement...

Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to: - maintenance of adverse event tracking systems. - set-up and maintenance of project files, core process files and central safety files. - assist with the reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance...

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

Summary Of ResponsibilitiesManagement of projects under direction of a Project Manager/Director as assigned.Ensure site monitoring responsibility for clinical studies is conducted according to Fortrea Standard Operating Procedures (SOP), ICH Guidelines and GCP.Work closely with project teams in implementation of best trip report review practices and...

Summary of Responsibilities:Management of projects under direction of a Project Manager/Director as assigned.Ensure site monitoring responsibility for clinical studies is conducted according to Fortrea Standard Operating Procedures (SOP), ICH Guidelines and GCP.Work closely with project teams in implementation of best trip report review practices and...