The EDC Developer is responsible for building and maintaining EDC applications, including structure, workflow, edit checks, and user permissions. They also create study-level documentation and manage post-live system changes under the change control process.
The EDC Developer is responsible for building and maintaining EDC applications, including structure, workflow, and edit checks for complex clinical projects. They also create study-level documentation and manage post-live changes under the established change control process.
The EDC Developer is responsible for building and maintaining EDC system structures, workflows, and edit checks for complex clinical projects. They also create study-level documentation and perform post-live system changes under change control processes.
The Senior Site Contracts Specialist is responsible for drafting, negotiating, and executing clinical site agreements and amendments to support study startup and maintenance. They act as a subject matter expert, collaborating with project teams to ensure timely delivery and regulatory compliance.
The Project Data Manager is responsible for the end-to-end planning, execution, and closure of clinical data management projects. They lead internal teams and external vendors to ensure data quality, budget adherence, and timely delivery of project milestones.
The PV Officer will manage ICSR activities, including processing cases, performing quality control, and maintaining project-specific KPIs. They will also act as a subject matter expert and support the Regulatory Affairs and Pharmacovigilance department as a local contact person.
The Manager, Statistical Programming provides leadership and oversight for a global team, ensuring the delivery of high-quality clinical trial data products. They are responsible for managing project timelines, budgets, and resources while mentoring staff and driving departmental process improvements.
Perform on-site and remote monitoring visits to ensure clinical trial sites maintain adequate facilities, staff, and data quality. Support regulatory and ethics committee submissions while training investigational site staff throughout the study period.
The Manager, Statistical Programming provides leadership and oversight for a global team, ensuring the delivery of high-quality clinical trial data products. They are responsible for managing project timelines, budgets, and resource allocation while fostering team development and process excellence.
The role involves acting as a franchise liaison between the company and clients to manage complex regulatory and pharmacovigilance projects. Key duties include providing strategic guidance, managing delivery targets, and assisting in securing new business through proposals and budgets.
