When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Core services provided by the Senior Project Specialist include, but are not limited to:
- Project Management Plans initial set up and maintenance with Project Leader and Functional Lead input, communication of plans to the wider project team and support with execution of the plans.
- Maintenance of selected information in the integrated project management system and leading work 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 analysis of data; initiation and follow up on required actions in alignment with PL and FLs
- Review of selected financial areas and follow up with stakeholders on required corrections. Provide reconciliations to PL, as agreed.
- Cooperation with Project Leader and Functional Leads on different action plans and follow up with the project team until action completion.
- Oversight of project team list, project system accesses and respective reviews; development of respective processes and roll out to the project team as needed.
- Team leadership in specifically defined areas when working on PL behalf.
Project Initiation Management
- Independently updating and customizing 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, suggesting and following through appropriate actions to reduce overconsumption, review plans with PL and FBP; Reviewing pass – through costs, supporting timely invoicing; 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, supporting resource escalations; 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. Applying team leadership when cooperating with the functions on TMF compliance and investigator payments oversight
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, presenting selected areas in MPOR and other meetings; Providing reports, metrics and analysis for informed Project Leader decision making, client reporting and risk management. Maintaining oversight on project system accesses and ensuring timeliness of access 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 till completion.
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, following up with vendors on questions and queries regarding invoices.
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.
Clinical Operations Leader Support
- 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.
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; present topics and provide expertise in local and global department meetings
Competency Levels for the Senior Project Specialist (refer to PPS Competency Guide for more detail)
- Project Management – Superior
- Financial Management – Advanced
- Analytical Mindset – Superior
- Quality Delivery – Superior
- Team Oriented approach – Superior
- Ownership – Superior
- Communication – Superior
- Client Focused approach – Advanced
- Risk Management - Proficient
- Professionalism – Superior
- Superior - notable strength, possessing a special talent, and viewed as being better than most – capable of coaching for and teaching this competency.
- Advanced - mature understanding of competency and excellent ability to apply competency in multiple situations- capable of teaching the basics of this competency to others.
- Proficient - robust understanding of competency and solid acquisition of the skills required to use the competency - can successfully apply it without management supervision.
Skills:
- Excellent 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
- Openness to new learning and role modelling adoption to change
- Ability to manage multiple and varied tasks with enthusiasm and to teach others in these tasks
- Willingness to work in a matrix environment and to value the importance of teamwork
- Ability to facilitate cross functional and teamwork towards a goal.
- Excellent problem-solving skills
- Ability to apply analytical thinking to resolve issues in a variety of complex situations
Knowledge and Experience:
- Minimum two years’ experience in a PS II role or in an equivalent role
- In-depth understanding of how their role integrates with others in the business in accomplishing project deliverables and the objectives of the area
- Excellent understanding of project management and applicable tools
- Developed financial understanding
- Mentoring or training experience
- Basic understanding of the business and market
- ICH/GCP knowledge
Education:
- Advanced English level for non-native English speakers
- Minimum Bachelor’s degree or equivalent degree