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 Project Manager may also take the role of Portfolio Manager, or be the Project Manager of more than one study. Project Managers will work to ensure successful execution of a study to time, budget and quality indicators. Will be responsible for leading a team to successful completion of study deliverables and meeting or exceeding client expectations. Responsible for tracking resource requirements and projections within a study, identifying out of scope activities and escalating to Portfolio Managers; manage team time spent on a study with a view to meeting study realisation targets; identify and escalate areas for process improvement with a view to increased efficiency of study conduct. Collect study metrics 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 Portfolio Managers regarding study status, issue escalation, KPI indicators, quality issues, and resourcing requirements.
Responsibilities
Employees may be required to perform some or all of the following:· Implement long-term and short-term PMO goals according to company objectives.· Contribute to, and understand contractual documents.· Execute project start-up and prepare the team for/and attend Kick-off meetings.· Prepare for/organise external and internal study team meetings and produce minutes.· Create and maintain communication plan.· Create and maintain project risk registers.· Create and maintain study wide documentation.· Ensure projects are delivered to agreed timelines and using correct SOPs.· Ensure projects are delivered efficiently, all project team members must achieve utilisation targets.· Provide support to the project team.· Forecast project resource needs using PHASTAR tools.· Highlight out of scope work to the Portfolio Manager. · Review, approve, and communicate to finance milestone payments. · Attend Project Managers meetings to discuss study and portfolio resourcing requirements. · Attend project review meetings to update on study status. · Ensure team follow relevant SOPs and escalate quality issues to the Portfolio Manager. · Monitor quality KPIs and respond and action where a KPI is missed. · Represent PHASTAR in front of the customer, be the primary point of contact, escalate issues as appropriate. · Maintain agreed level of repeat business from existing customers. · Attend bid-defence meetings as prospective Project Manager.
Qualifications
· PhD or MSc in Biostatistics, mathematics, life sciences or a related discipline.· Experience within the pharmaceutical industry to have an 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.
