Centralized Study Spec 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. Conducting operations in...

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...

Follow all applicable departmental Standard Operating Procedures and Work Instructions. Complete required trainings according to required timelines. Complete day-to-day tasks ensuring quality and productivity. Manage project and technical documentation in an appropriate manner. Provide administrative and technical support to internal departments and teams as...

To complete Other duties/activities as assigned by study management team, but not limited to: Manage clinical systems & access management Manage study documents such as study level, country level and site level Maintain study databases (CTMS, IWRS, EDC etc.) Support study team in e-TMF management activities Support study team in data review and support...

Job Overview Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and...

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 accordance...

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...

SSUA I, Bangalore, 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 We are currently seeking a Study Start Up Associate I to join our...

Position SummaryThe Senior Central Monitor will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments,...