What the Clinical Systems Department does at Worldwide 

Our Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. The department works closely with industry specific systems such as: IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF and CTMS. The department has various roles including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists. Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally. 

What you will do 

• Provide project management oversight from maintenance to eCOA decommissioning, including oversight and accountability of deliverables and timelines and completion of work to Worldwide SOP standards 

• Review and identify study trends and proactively work with eCOA vendor and study team to address study specific requirements 

• Communicate information on applicable eCOA project activities to stakeholders, including internal and sponsor study teams. Serves as the escalation point of contact for all eCOA assigned study-related project issues 

• Overall accountability for coordination and timely delivery of eCOA project communications including study status reports, meeting agendas and minutes and scheduling project calls 

• Responsible for overall eCOA study design review and approving User Requirements Specification (URS) for post go-live Change in Scope 

• Prepare, review and approve site and support materials as well as helpdesk documentation, when required 

• Perform financial review and budget management, including review of Change Orders 

What you will bring to the role 

• Ability to communicate concisely and effectively in both written and spoken English 

• Proficient client-facing skills 

• Self-motivated individual who can positively contribute to a team environment with the ability to prioritize and handle multiple projects simultaneously 

• Flexible and able to use sound independent judgment and take initiative to assess information 

• Able to make effective decisions in a fast-paced, highly dynamic environment 

• Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems Highly organized, detail- and service-oriented 

• Excellent project management skills 

Your experience 

• Educated to degree level in a relevant discipline or able to demonstrate equivalent experience Minimum 1 year of experience working in eCOA and clinical trials Minimum 1 year of experience in project management The individual must demonstrate an ability to lead, understand policies and procedures, financial and leadership principles, possesses excellent time management and project management skills and communicate effectively. 

• Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials  

• Has knowledge of the Software Development Life Cycle (SDLC) and be familiar with eCOA topics, including eCOA designs and scales Contract Research Organization (CRO) or pharmaceutical experience required 

• Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business) The role may require travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.