Overview
PHASTAR has established a Project Management Office to formalise the management of projects. The program of work is divided into portfolios, with each portfolio being overseen by a Portfolio Manager. A portfolio can be defined based on client, location, therapeutic area and function, and may comprise of one to multiple studies depending on complexity, scope and size of study. Each study is assigned a single Project Manager, who will co-ordinate the Statistics, Programming, and Clinical Data Management activities in addition to managing third- party vendors within the study. Depending on size of portfolios a Portfolio Manager may also take the role of Project Manager for one or more studies, or oversee more than one portfolio. Portfolio Managers will oversee the program of work within their portfolio to ensure successful execution of the entire schedule of work to time, budget and quality indicators. Will be responsible for the overall resourcing requirements and projections within a portfolio, oversee and support Project Managers with regards to resourcing of studies, identifying out of scope activities and escalating to Account Managers; oversee and manage portfolio utilisation and realisation targets; identify areas for process improvement with a view to increased efficiency of study conduct. Ensure consistent methodology of metric tracking in order to facilitate benchmarking of study performance against budget and KPI collection. Member of the Project Management Office; work with and report back to Head, PMO regarding portfolio status, issue escalation, KPI indicators, quality issues, and resourcing requirements
Responsibilities
Employees will be required to perform some or all, of the following:· Implement and track long-term and short-term PMO goals according to company objectives.· Forecast portfolio resourcing requirements through resource capacity and demands.· Assignation of projects within a portfolio.· Ensure appropriate balance of roles and experience within studies and implement flexible resourcing strategies.· Monitor quality KPIs across portfolio of work.· Track utilisation and realisation targets within a portfolio.· Create and review portfolio status report.· Handle portfolio/project issue resolution in conjunction with Account Managers, or escalate to Head, PMO.· Input into project review meetings for portfolio/project status updates.· Attend Portfolio Managers meetings. · Provide support for Project Managers working within the portfolio. · Organise & attend Project Managers meeting within each portfolio. · Raise out of scopes and contractual issues with Account Managers. · Work with QA to ensure portfolios/projects are conducted according to SOPs & regulatory requirements; review, implement audit and CAPA findings which affect operational processes with a view to continual process improvement. · Raise quality issues/CAPAs to QA which occur within the portfolio. · Adhere to PMO SOPs. · Ensure consistency in processes across studies, and best practices shared. · Attend meetings with Account Managers/Sales regarding customers within portfolio. · Provide Operational Strategy to Business Development as part of the sales pro
Qualifications
· PhD or MSc in Biostatistics, mathematics, life sciences or a related discipline. · Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation.· Familiarity with GCP and regulatory requirements.· Working in a cross functional environment, with experience of leading studies to completion.· Experience with project management or resource management and working with budgets on multiple studies.
