The RoleResponsible for the day-to-day management and completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget under the guidance of the Exec. Director, PM and Client ServicesTo ensure excellence of service with the Sponsor throughout the projectTo provide support to project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budgetTo comply & adhere to GCP guidelines and regulations as required of this roleTo ensure subject safety at all timesMain tasks and responsibilitiesMaintain contact with the Sponsor from project initiation to operational close out for allocated studiesLead the internal project team to ensure timely project communication and delivery throughout the life of the project for allocated studiesMonitoring and control of allocated project progress to time/quality/costInvoicing and debtor managementManagement of third party and internal suppliers as requiredDocumentation of study related communication e.g. minutes, t-cons, risk registers & issue logs in a timely mannerGeneration, review and approval of appropriate study-related documentation and reports in line with SOP requirementsChair lessons learned meetings as appropriateWork with the internal team to identify and have mitigation strategies for project specific riskManagement of study execution to ensure regulatory approvals, pharmaceutical development work, recruitment and screening of volunteers, clinical manufacturing, clinical operations and data sciences activities are delivered for customersManagement of close out of studies to ensure data queries, post-study reporting to the regulatory authorities, scientific review meetings and archiving are completed in a timely manner for allocated studiesPreparation of participant information and consent forms and management of the review processTracking of allocated projects and issues in MS Project on a real time basisOversight of the Investigator Site File and Trial Master File as requiredApplication of lessons learned from previous studies to ensure continuous improvement in deliveryHost Sponsor monitoring visits as requiredOversight of data query resolutionSupport other aspects of the business as neededAdditional Tasks/responsibilities Coaching, Mentoring & training abilityThe CandidateMinimum Degree qualification or equivalentAt least 2 years of experience of working in a clinical research/manufacturing environmentAbility to communicate effectively with internal and sponsor team