Job Description

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.

About this Role;
The Project Specialist I

* is responsible for developing project plans, providing project level reports and metrics to inform project oversight, progress reporting and decision making by the Project Leader (PL) and Functional Leads (FLs), to ensure timeliness and quality of project deliverables and control the project budget.

* will be predominantly assigned to late phase and Enterprise projects.

* is working under Line Manager oversight in all project lifecycle phases and depending on the acquired experience and independence, an assignment to Biotech& Emerging client’s projects, as well as to assist project start up and close out can be considered.

Knowledge and Experience you will require

-Relevant basic experience in a Project Specialist / Project Planning & Support type or similar role will be an advantage

-Basic knowledge of activities and procedures of the Project Planning & Support work area and processes (related industry exposure and / or experience, ie. Clinical Research, would be preferred)

-Good Knowledge of Microsoft based applications

-ICH / GCP knowledge will also be advantageous

Minimum Education Levels Required:

• Minimum Bachelor’s degree or equivalent degree (health / medical / life sciences preferred)

Skills Requirements:

• Good verbal and written communication skills, as the exchange of information is a significant part of the job. Intermediate to Advanced English proficiency is essential

• 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

Core services provided by the ProjectSpecialist I 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

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.

Project Execution and Control Management

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

Project Integration Management

• 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.

Project Meeting Management

• Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; 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.

• 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

• 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.