Associate eCOA Manager - US - Remote

Worldwide Clinical Trials•Durham, NC

2d•$71,500 - $142,500•Remote

About The Position

We are a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. 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.

Requirements

Proficient client-facing skills
Proficient in the use of common office software
Self-motivated individual who can positively contribute to a team environment
High attention to detail
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
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)

Responsibilities

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