Drive study performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents. Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
Contribute to the selection of potential sites and investigators. Train, support and advise Investigators and site staff in study related matters.
Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. Manage study supplies, drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data.
Ensure accurate and timely reporting of Serious Adverse Events.
Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centres as per required timelines.
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.