Project Management Plans initial set up and maintenance with Project Leader input
Maintenance of selected information in the integrated project management system and working with other functions on compliance of data in the project systems
Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight, including initial analysis of data
Review of selected financial areas and follow up with stakeholders on required corrections.
Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team until action completion.
Oversight of project team list, project system accesses and respective reviews
Project Initiation Management
Updating and customizing of systems and tools and project plans according to applicable SOPs; Supporting vendor selection; Creating of Project specific training curriculum; Reviewing time booking and analyzing overconsumption with FL input ready for PL review; Reviewing pass - through costs; Cooperating with TMF lead, IPO and eCBL on set up on TMF and sitepay; Cooperating with Project Data Coordinator to set up system access management process; Working with PL and FLs to ensure project resources are requested in line with project scope; Collecting, distributing and tracking insurances and Letter of Authorization
Project Execution and Control
Management
Study reporting and analysis with subsequent highlighting issues for project team. Maintaining systems and tools according to applicable SOPs. Project Integration Management Maintaining consistent coherent project management plans, including communication, coordinated planning of the different project activities and input from the different functions; collaborating with the PL and FLs to execute the plans. Reviewing time booking and analyzing overconsumption with FL input ready for PL review; Reviewing pass - through costs; Reviewing Project Specific Training Compliance and following up on non- compliances; Assisting with preparation conduct and action follow of Project Operational review meetings; Providing reports, metrics and analysis for informed Project Leader decision making client reporting and risk management. Maintaining oversight on project system accesses and review. If delegated, provide oversight on defined project management areas on behalf of the Project Leader.
Project Meeting Management
Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Reporting of owned responsibilities during meeting attendance; Supporting tracking and follow-up of action items.
Project Vendor Management
Collaborating with PL and FLs to ensure study supplies are delivered as required and according to contract obligation. Performing vendor invoice review.
Project Closure Management
Close out responsibilities: utilizing the close out checklist and communicating to drive timely operational projects close out with the different functions. Collaborating with PL on ensuring that systems are closed, documents are archived, and final work is handed over to the sponsor. Support preparation of the financial close out.
SME /Mentor, if assigned
Train and mentor new starters in systems and tools. Provide feedback to PS/PL Super User in CRS technology on systems and tools in order to enhance tools and processes
Competency Levels for the Project Specialist II (refer to PPS Competency Guide for more detail)
Professional interpersonal, verbal and written communication skills, as the exchange of information is a significant part of the job
Attention to detail and understanding how quality of own work impacts others and the business outcomes
Client focused approach to work
Flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and to adopt to changes
Ability to prioritize workload
Willingness to work in a matrix environment and to value the importance of teamwork
Advanced problem solving skills
Ability to apply analytical thinking to resolve issues
Knowledge and Experience
:
Minimum one year experience in the PS role or more than 2 years' experience in Clinical Research
Good understanding of how their role integrates with others in the business in accomplishing the project deliverables and objectives of the area
Experience in working globally across regions
IH /GCP knowledge
Education:
Intermediate to Advanced English level for non-native English speakers
Minimum Bachelor's degree or equivalent degree
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