Clinical Systems Manager

Ideal Candidate: The ideal eCOA Technical Specialist will have 3 years of experience with eCOA vendors (e.g., Clario, Signant Health, Medidata, Clinical Ink) and a solid understanding of eCOA technical specifications, timelines, and governance processes. They should have a proven ability to manage projects, troubleshoot issues, and advise on translation and licensing processes. Strong project management skills, including managing timelines, vendor relationships, and escalations, are essential. The candidate must also excel in collaboration and communication, guiding global clinical trial managers on best practices, and documenting processes in systems like Merit. A positive, team-oriented personality, adaptability to remote work, and professionalism in cross-functional settings are critical. While a bachelor s degree is preferred, hands-on eCOA experience is prioritized over formal education. Candidates with steady employment histories (2-3 years per role) are preferred.

Key Responsibilities include:
* Accountable for quality delivery and competencies within the eCOA service area
* Oversee study level system requirements meetings with eCOA vendors and internal stakeholders
* Assist in the design and development of study specific technical documents
* Support the internal team in managing project related timelines and associated activities
* Partner with data management (DM) to define the requirements for data transfers
* Work with external resources to manage the creation and execution of user acceptance tests
* Identify and track study-related technical issues to resolution
* Provide a supportive framework for continuous process and quality improvements

Basic Qualifications:
* Doctorate Degree OR
* Master's Degree and 3 years of Clinical experience OR
* Bachelor's Degree and 5 years of Clinical experience OR
* Associate degree and 10 years of Clinical experience OR
* High school diploma/GED and 12 years of Clinical experience

Preferred Qualifications:
* Bachelor s Degree in life science, computer science, engineering, business or related discipline
* 4+ years of experience in clinical development
* Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry
* Knowledgeable in Good Clinical Practices, and FDA regulations necessary
* Project management and technical expertise, attention to detail, and excellent documentation and communication skills
* PMP
* Previous vendor management experience
* Excellent time management and organization skills
* Have sound problem resolution, judgment, and decision-making abilities
* Be able to work well in a team-based environment with minimal supervision