What are the responsibilities and job description for the Clinical Systems Manager position at The Steely Group?
Responsibilities :
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
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
