Job Description: Perceptive Informatics, the technology subsidiary of PAREXEL International Corporation, is the industry's leading eClinical solutions provider and we help customers accelerate the drug development process through innovation. Our product portfolio is built on leading-edge technology and is combined with extensive medical and clinical expertise as well as a deep understanding of the regulatory environment. Our product design methodology is geared towards aligning with our customers' processes and we're merging the boundaries between products that traditionally have been used in isolation. This results in simplified workflow for customers and represents a radical shift in the way technology is used in clinical trials. Our eClinical solutions help biopharmaceutical companies improve efficiency and productivity, and ultimately reduce the costs associated with clinical research.
Perceptive Informatics' products and services include Randomization and Trial Supply Management solutions; Clinical Trial Management Systems (CTMS); Electronic Data Capture (EDC); Interactive Voice Response (IVR)- and device-based electronic patient reported outcomes (ePRO); integration services; and web-based portals, tracking tools and investigator database solutions.
Summary: The Project Associate is an integral member of the Operations department, providing support and troubleshooting on various aspects of projects for the clinical project teams.
Essential Duties and Responsibilities (other duties may be assigned):
- Deliver a positive, memorable and meaningful service which exceeds the expectations of both the internal and external customer.
- Attend local investigator and project specification design meetings.
- Participate in study design meetings along with the Project Manager, including teleconferences and in-person client meetings.
- Liaise with UK and inter-departmental colleagues on project-related issues.
- Provide backup to the Project Managers (PMs) on project-related duties.
- Troubleshoot on live study issues for the Project Managers.
- Create end-user documentation, call flow charts and other study-related documents as necessary.
- Create unit testing for test plans and execute testing.
- Prepare and collate completed study validation packages for transfer to the UK for the Project Managers.
- Support the client testing process by being available to assist clients with any issues.
- Raise Project Amendment Forms (PAFs), test PAF changes and follow through to completion and go-live.
- Update Specifications and other study-related documentation as necessary.
- Communicate with clients as necessary on any aspect of the projects.
Competencies and Qualifications: This job requires a person to be highly customer focused with excellent computer skills, including proficiency with MS Office. This position requires organizational skills with a high attention for detail. The ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals is necessary. Excellent verbal and written communication skills are essential.
Education and Experience: Bachelor's degree preferred with one to two years of experience working in a client-based environment within the CRO, research or biopharmaceutical industries.
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