Clinical Operations

• Support GPs with clinical results, follow-ups, and patient communication
• Contribute to incident reviews and quality improvement initiatives
• Deliver nurse-led patient follow-up and triage
• Reduce GP administrative load while maintaining high clinical standards

Clinical Operations Nurse

• Work with study teams across a variety of functional areas to ease bandwidth strain on Coordinator responsibilities detailed below.
• Processing clinician/rater forms and documenting data via status trackers and ePortal/LMS training systems.
• Review and process submitted clinician/rater surveys and deploy applicable LMS training modules.
• Schedule 1:1 training video conferences between site raters and Cogstate Rater Services staff
• Hardware shipment scheduling and documentation management.
• Documenting real time updates to applicable status trackers, coordinating high volume email correspondence, communicating status updates to clinicians/raters, electronic records filing.
• Point of contact for clinician/rater support questions.
• Direct communication with site coordinators at clinical settings, activity and communication tracking and general support throughout study.
• Interact with CRAs for site monitoring activities.
• Provide customer service and translations from English to Japanese and vice versa when needed.

Coordinator, Clinical Operations

• Lead the planning, execution, and delivery of clinical trials in line with contracts and regulatory standards (ICH-GCP, local laws)
• Develop and implement integrated study management plans with core project teams
• Serve as the primary point of contact for clients, vendors, and internal stakeholders
• Monitor project performance, manage risks, and drive resolution of issues
• Ensure financial success through accurate forecasting, budget control, and scope management
• Mentor and support junior team members, fostering a culture of excellence and collaboration
• Represent IQVIA in bid defenses and client meetings, showcasing our capabilities and solutions

Associate Clinical Project Manager

• The Project Manager is responsible for the development, conduct and completion of research projects in accordance with the reasonable requirements of the originator of the project.
• The Project Manager is responsible for all aspects of study management activities including cross functional team Leadership and co-ordination, Client communication/ management, financial management and Overall study delivery.
• Project Manager must ensure studies are resourced effectively, managed efficiently, achieve project objectives within allocated budgets and agreed timelines and are conducted to the highest standards of Good Clinical Practice (GCP), regulatory requirements and applicable Standard Operating Procedures (SOP).
• The Project Manager mentors/coaches Junior Project Management staff or Clinical Delivery Leads and assists their technical development.

Clinical Project Manager / Senior Project Manager

• Manages staff, providing coaching, mentorship and work direction.
• Conducts regular performance appraisals and career discussions with staff.
• Facilitates employee career development.
• Interviews, recruits and selects staff.
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
• Ensures timeliness and accuracy of timesheets and expense reports.
• Supports allocation activities per the local resourcing process.
• Supports activities of project leads/functional leads to optimize the operational running of projects.
• Raises appropriately any issues which may impact project deliverables at a country level.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations.
• Identifies training gaps and ensures that training requirements are met.
• May contribute to development of training programs, where appropriate.
• Assures adherence to good ethical and regulatory standards.
• Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
• Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk-based monitoring approach.
• May provide input into bids and contribute to the procurement of new business where required.
• Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.
• May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

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Clinical Operations Nurse

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