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...

1. Follow all applicable departmental Standard Operating Procedures and Work Instructions. 2. Complete required trainings according to required timelines. 3. Complete day-to-day tasks ensuring quality and productivity. 4. Maintain project and technical documentation in an appropriate manner. 5. Perform checks to ensure quality of work completed 6. Ensure...

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...

Support the payment of assigned studies which could include study set-up, maintenance, timely and accurate payment to the sites, as well as issue resolution and study reconciliation. Provide excellent customer service and site issue resolution Assist in setting entering study budgets and payees Review Electronic Data Capture updates and determine when...

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...

Central Monitor **Category**:Clinical Development**Location**:Bangalore, Karnataka, IN **Department - Centralised Monitoring Unit (CMU) - Bangalore**About the department** - The Centralised Monitoring Unit (CMU) - Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers),...

Study Start Up Associate I - India, Bangalore Hybrid: Office based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people...