... is responsible for managing client studies within Clinical Operations and or ... with the contract, timelines and study budget Identification and review of ... -up Ensure all necessary study specific training is provided to study team to improve performance and ...
... administrative support of international Studies: Maintenance of Trial Master File ( ... applicable systems trackings for Study specific activities - set up of ... up with other study team members Support in Study documents translation and translation verification ...
... conduct and oversight of clinical studies in academia or industry is ... but not limited to the study protocol, informed consent form, statistical analysis plan, case report form, clinical study report Provide scientific, clinical development ...
... or site re-training) Provides study-specific CSAI-OS training for ... on review findings Develops applicable study-specific monitoring CRA and data ... Clinical Research Associate (CRA) or Study Coordinator Research Nurse preferred. Oncology ...
... closing activities of the appointed studies in compliance with local regulations, ... , providing insightful input on local study start-up strategy and regulatory ...
... of clinical trials to the study protocol, ICH-GCP guidelines, and ... , medical devices, and non-interventional studies) in accordance with applicable regulations, ... . Conduct feasibility assessments and pre-study evaluations. Document activities in compliance ...
... integrity, and compliance with all study procedures. Monitor study timelines, patient recruitment, budget Participate ... a CRO Experience in commercial studies Experience in clinical studies phase II-III Fluent English & ...
... may serve as a study lead Liaise with potential investigators ... others. Lead and support study meeting activities as aligned with ... may serve as a study lead Liaise with potential investigators ... others. Lead and support study meeting activities as aligned with ...
... the Project Manager and core study team to ensure that project ... and external system access for study participants Developing and maintaining project ... , newsletters Managing site supplies printed study materials and coordinating timely distribution ...
... supply chain solution for PSI studies Build and maintain a drug ... . Manage the IRT vendor - lead study specific system set-up, UAT, ... and IRT vendors for PSI studies Support and train PSI teams ...