Software Design Project Manager / Design Project Manager - Research Triangle Park, NC

Location -

Software Design Project Manager/Design Project Manager

 – Research Triangle Park, NC

Cenduit, LLC, a joint-venture between Quintiles and ThermoFisher, is looking for a Design Project Manager for our location in Research Triangle Park, NC.  This is a rare opportunity to join a new organization in the early stages and be part of our exciting future!  Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and clinical supply chain expertise from two world leaders.  Cenduit provides clients with state-of-the-art Interactive Response Technology (IRT) to gather, analyze, and integrate data from clinical trials faster and more efficiently than ever before.

Purpose:  Manage and co-ordinate the scope, timelines, and delivery of the design, specification, build, testing, client acceptance, and deployment aspects of a project during the build phase, or when sizeable design revisions are required for a live study. 

The role will be responsible for guaranteeing that all study build tasks are completed to the sponsor’s satisfaction, ensuring quality deliverables according to the study project plan, within budget, and in accordance with Cenduit’s SOP’s policies and procedures.

Primary Responsibilities

• Serve as technical design analyst for new Interactive Response Technology (IRT) system projects and changes to existing systems from initial discussions with clients, developing project requirements, documenting aspects of the system design; establishing system design framework.   
• Ensure that all project work is completed to the sponsor’s satisfaction, enduring quality deliverables on time and within budget and in accordance with the standard operating procedures policies and procedures. 
• Coordinate and communicate all technical activities internally, to design a clinical systems that meets the needs of the study  
• Author design specification and other project documentation to support the development and use of a clinical system.  Work with the project team to finalize the requirement documents so that the systems can be delivered as required by the client. 
• Use appropriate project planning tools (Microsoft Project) to communicate milestones and critical path activities and responsibilities. 
• Ensure that activities come together in a timely manner to meet the client and study requirements, including regular communication with team members to ensure project tasks are on target. 
• Management of the system lifecycle (SLC), Project Validation Testing (PVT), user testing (UAT) and the ‘go live’ process.   
• Assist with issue identification, documentation, and escalation. 
• Lead problem solving and resolution efforts. 
• Act as technical lead on project and participate in client meetings for requirements and follow up meetings, as required   
• Develop and oversee maintenance of internal database and project plans; 
• Partner with other project manager on a cross functional basis to develop and implement business process improvement activities; 
• Prepare and present project information at internal and external meetings; 
• Ensure that work is conducted in accordance with standard processes, policies and procedures and meets quality and timeline metrics; 
• Collaborate with Technical Support group to ensure they have all the necessary information in order to set up systems.

Skills

• Excellent communication skills, both written and verbal
• Strong customer service ethic with ability to establish and maintain effective working relationships with co-workers, managers and clients
• Good problem solving and organizational skills
• Accuracy, with an eye for detail and results focused
• Analytical decision making
• Team player & flexible
• Good computer skills, including knowledge of MS office applications
• Knowledge of the drug development process and GCP

Education & Experience: 

• Bachelor's degree in sciences, technology, engineering, or related field
• 3-5 years clinical research or pharmaceutical experience
• Minimum of 2 years technical project management experience. 
• Experience in a key CRO/Pharmaceutical operational function, e.g., data management, clinical operations, laboratory, pre-clinical; or equivalent combination of education, training and experience is desired. 
• Experience with Interactive Voice Response (IVR) or Electronic Data Capture preferred
• Experience in software development process, including system software testing and release. 

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