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As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives. In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.
Job Responsibility:
Leading cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborating with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Core services provided by Project Specialist I and Project Specialist II include but are not limited to: Project Management Plans initial set up and maintenance with Project Leader input
Maintenance of selected information in the integrated project management system
Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight
Initial Review of selected financial areas
Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team on action items
Oversight of project team list, project system accesses and respective reviews
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 following up on needed corrections 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 site pay
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
Study reporting and distribution to FLs and project team
Maintaining systems and tools according to applicable SOPs
Maintaining consistent coherent project management plans, reviewing plans with PL and distributing to the different functions
Providing reports, metrics and initial analysis for informed Project Leader decision making and client reporting
Assisting with preparation and action follow of Project Operational review meetings
Maintaining oversight on project system accesses and review
Project meetings preparation and attendance
Supporting preparation of required information for internal and client meetings
Supporting tracking and follow-up of action items
Collaborating with PL and FLs to ensure study supplies are delivered as required and according to contract obligation
Performing vendor invoice review
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
Supporting the Clinical Operations Leader with different responsibilities to manage CTMS system compliance, site newsletters track and analyze different reports such as site staff lists, shipment reports, laboratory reports, site contact reports, site closure activities related tracking, vendor reports, query reports and other responsibilities as delegated
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
Requirements:
Good verbal and written communication skills
Developed interpersonal skills and ability to build relationships
Attention to detail and quality of work
Client focused approach to work
Flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm
Ability to prioritize workload
A willingness to work in a matrix environment and to value the importance of teamwork
Basic problem- solving ability
Professional interpersonal, verbal and written communication skills
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
Relevant basic experience in a PS type or similar role desirable
Basic knowledge of activities and procedures of the work area
Good Knowledge of Microsoft based applications
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
ICH /GCP knowledge
Intermediate to Advanced English level for non-native English speakers
Minimum Bachelor's degree or equivalent degree
What we offer:
Supportive work environment
High degree of empowerment and accountability
Flexible work arrangements (remote, in-office and hybrid roles)