Associate eCOA Manager - US

Worldwide Clinical Trials•Sacramento, CA

18h•Remote

About The Position

Worldwide Clinical Trials is a global, midsize CRO that is dedicated to pushing boundaries and innovating in the pursuit of cures for persistent diseases. We are a global team of over 3,500+ experts committed to changing the way the world experiences CROs. Our mission is to work with passion and purpose every day to improve lives. The Clinical Systems Department plays an essential role by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. This department works closely with industry-specific systems such as IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF, and CTMS. The department offers various roles including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists, with opportunities for mentorship, training, promotions, and internal growth.

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
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
Fluency in English (will be 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.
Serve as the escalation point of contact for all eCOA assigned study-related project issues.
Have 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.
Perform financial review and budget management, including review of Change Orders.