Planning and coordinating the overall and day-to-day management of a clinical trial. Supervising the overall conduct of a clinical trial in terms of progress, timelines, resources and quality standards.Act as principle contact person, internally for the HarmonyCR study team and externally for the client and any third party vendors involved in the clinical trial.

Contributing to the development and management of budgets, timelines and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.Compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data.

 Appointment and onboarding of any new resources in line with ongoing demand. Assign and allocate required resources to tasks / protocols to fulfil unit services. Responsible for the development and delivery of Training Materials for uCRAs and to ensure compliance with the relevant training plans. Responsible for service delivery oversight and management of the operational study management teams per study for the unblinded monitoring. Reviewer / Approver of unblinded monitoring visit reports. Manages the successful design, implementation, tracking and revision of the project plans to achieve project objectives (patient recruitment / safety, site compliance, study milestones). Set up and maintain the communication plan with the client. Solution orientated support of client management team in case of project issues. Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects / tasks. Ensure smooth project handover and collaboration with the client to fulfil the agreed services per CSA on the assigned projects. Regular interaction with client to discuss projected unblinded units and quality of completed unblinded units and any action to be implemented to reach client expectations of the unblinded monitoring. Follow up of the KPIs agreed between Covance and Client.

• Conduct site monitoring of clinical research studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP• Provide clinical support for projects according to Covance Standard Operating Procedures, ICH Guidelines and GCP• Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP

• Provide clinical support for projects according to Covance Standard Operating Procedures, ICH Guidelines and GCP• Develop and/or maintain tracking systems for clinical projects• Assist in field monitoring responsibilities as assigned by supervisor

• Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations.• Maintenance of allocated site’s information in the Trial Tracker TM Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.• Working with staff in Operational Strategy and Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.• Final review and approval of regulatory documentation for sites managed by another GSS professional.• Where applicable, provide logistical support for clinical trial supply coordination.