Overview
The PHASTAR Project Management Office (PMO) was established to formalise the management of projects across the organisation. Senior Portfolio Managers/Project Directors are key members of the PMO, who oversee at least one portfolio of work within the company. A portfolio can be defined based on client, location, therapeutic area and function, and comprise 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. Senior Portfolio Managers/Project Directors will oversee the program of work within their portfolio(s) to ensure successful execution of the entire schedule of work to time, budget and quality indicators.
In order to support these activities, the Senior Portfolio Manager/Project Director will work with commercial and finance colleagues. They will be responsible for the overall resourcing requirements and projections within a portfolio, oversee and support other Portfolio Managers and Project Managers with regards to resourcing of studies, identifying out of scope activities and working with the Account Managers to include these in contract change orders; 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. Line management responsibilities may also be required for individuals within the PMO.
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 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.· 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. · Work with Account Managers to put together initial contract and budgetary requirements for new studies. · Work with Project Managers to raise out of scopes and document these in contract change orders · 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 process. · Perform line management responsibilities for employees within the PMO.
Qualifications
· 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.
-Some level of exposure to biometric processes, tasks and responsibilities and how they fit into the wider clinical trial conduct lifecycle.