Key Accountabilities:

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

Project Initiation Management

Project Specialist I And II:

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.
The Project Specialist I may require mentoring and line manager oversight particularly for responsibilities related to analysis of financial data or activities that require team management skills.

Project Execution and Control Management

Project Specialist I:

Study reporting and distribution to FLs and project team. Maintaining systems and tools according to applicable SOPs.

Project Specialist II:

Study reporting and analysis with subsequent highlighting issues for project team. Maintaining systems and tools according to applicable SOPs.

Project Integration Management

Project Specialist I:

Maintaining consistent coherent project management plans, reviewing plans with PL and distributing to the different functions. Reviewing pass – through costs; Reviewing Project Specific Training Compliance and following up on non- compliances; Assisting with preparation and action follow of Project Operational review meetings; Providing reports, metrics and initial analysis for informed Project Leader decision making and client reporting. Maintaining oversight on project system accesses and review.
The Project Specialist I may require mentoring and line manager oversight particularly for responsibilities related to analysis of financial data or activities that require team management skills.

Project Specialist II:

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 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 Specialist I:

Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Supporting tracking and follow-up of action items.

Project Specialist II:

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

Project Specialist I And II:

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

Project Specialist I And II:

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.
Depending on level of Knowledge and experience of the Project Specialist I can be supported by a close-out SME or Line manager.

Clinical Operations Leader Support

Project Specialist I And II:

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

Project Specialist II:

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 (refer to PPS Competency Guide for more detail)

Project Specialist I:

Project Management – Basic
Financial Management – Basic
Analytical Mindset – Basic
Quality Delivery – Beginner
Team Oriented approach – Basic
Ownership – Basic
Communication – Basic
Client Focused approach – Beginner
Risk Management – Beginner
Professionalism – Proficient

Project Specialist II:

Project Management – Proficient
Financial Management – Proficient
Analytical Mindset – Proficient
Quality Delivery – Advanced
Team Oriented approach – Advanced
Ownership – Advanced
Communication – Advanced
Client Focused approach – Proficient
Risk Management – Basic
Professionalism – Advanced
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.
Basic - understanding of the competency and has acquired the fundamental skills- can apply it under the guidance of management.

Skills:

Project Specialist I:

Good verbal and written communication skills, as the exchange of information is a significant part of the job.
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.

Project Specialist II:

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:

Project Specialist I:

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

Project Specialist II:

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

Education Project Specialist I And II:

Intermediate to Advanced English level for non-native English speakers
Minimum Bachelor's degree or equivalent degree

Logistics Project Specialist