Job Description

At least 10-12 years of experience in clinical research across all stages and phases of trials with previous exposure to line or matrix management preferred. Practical experience in handling Trial Master File activities including Paper or electronic - TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Line Management experience is essential. Responsibilities: Act as Line Manager for assigned staff including Team Lead, Centralised Document Management, DMA, SDMA and CDS. Work with the Resourcing Co-ordinator to identify appropriate project assignments for direct and indirect line reports, identify shortfall in resourcing and trigger hiring requests as necessary. Coordinate induction process for all new line reports on commencement of employment. Ensure line reports are aware of and understand company policies and procedures appropriate to their position. Ensure balanced workload and project assignments in line with employees skills and experience. Actively seek feedback and monitor the employee s performance metrics and KPIs, as well as the quality of their work, on an ongoing basis. Provide constructive and developmental feedback to ensure performance standards are maintained. Lead the team in developing all TMF-related processes, tools, training and working practices in collaboration with Senior Clinical Operations Management team. Provides expertise and best practices related to the TMF, including EDs, TMF processes and eTMF systems, and other clinical trial processes. Ensure the document quality requirements are agreed to and met by the study team, according to Completeness, Timeliness and Quality metrics. Responsible for ensuring projects are appropriately resourced to a DMA, SDMA, CDS.