IT Project Manager Cardiac Imaging BWH

The Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Women's Hospital, a Harvard-affiliated hospital. The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials, responsible for site training and interface as well as echo analysis of images received. The CICL works primarily with sponsors, CROs, and clinical trial sites which send echos directly to the CICL. There are approximately 50 staff supporting 40 clinical trials ongoing at any given time with a typical volume of 1000 - 1500 echos received each month.

This position serves as the CICL's Systems Director. This includes integrating new technology into workflow as well as overall technical and system-based improvement projects. Responsible for oversight and organization of CICL IT infrastructure, software, and systems. Works independently to develop and manage the CICL's compliance with applicable institution and regulatory requirements.

PRINCIPLE DUTIES AND RESPONSIBILITIES:

Center-Wide Leadership and Oversight:

• Develops and implements strategies and system-oriented solutions geared for maintaining growth and efficiency.

• Engages with technical vendors for needs assessments and solution development. Includes implementing new systems/software for successful roll-out and ongoing improvements.

• Leads operational design and execution to ensure that new applications address key performance objectives.

• Coordinates system-based workstreams across technical and project management staff.

• Develops ongoing support solutions in coordination with MGB ERIS, IT Security, and Research Compliance.

• Analyzes relevant data and provides performance reports all projects to ensure strategic alignment with CICL objectives.

• Leads operational and technical teams to facilitate engagement with applicable systems used in day-to-day operations. Includes creating, facilitating and leading project meetings, working groups, and status reporting presentations.

Information Systems Leadership and Oversight:

• Leads development and implementation processes for new systems/technology into the CICL.

• Serves as liaison between CICL and MGB Information Systems/Information Security personnel for issues as they pertain to CICL computer systems, data security, software development, infrastructure improvement, quality improvement, and workstation issues.

• Establishes efficiency and efficacy standards, providing recommendations for improvement of IT infrastructure and measuring productivity levels.

• Serve as liaison between external vendors for CICL software and analysis programs, including troubleshooting, software upgrades, and new software procurement.

• Initiate and track software development requests with external vendors and oversee testing, deployment, and documentation.

• Supports the CICL in audits and vendor qualifications in areas of IT/data security and compliance.

• Develops training materials including manuals and Standard Operating Procedures for software and analysis programs.

• Supports CICL Operational and Technical staff with hardware and software needs, including training and troubleshooting.

• Supports the CICL in sponsor facing communications pertaining to IT/IS systems used to execute project deliverables.

• Liaises with CICL Data Analyst to manage trial configuration, design, and workflow within the CICL data management portal.

• Works with CICL Technical Director, biostatisticians, and Data Management to ensure accurate configuration of trial parameters and assists in extracting data for quality control procedures.

• Maintains assignments and data for reproducibility assessments required for all CICL technical staff during onboarding and at regular intervals determined by the leadership team.

• Responsible for Risk Assessments and implementing Change Control processes for CICL applications.

• Works with MGB Disaster Recovery Team to develop and execute Disaster Recovery tasks.

• Works with MGB Information Systems groups to identify, triage, and document systems vulnerabilities.

• Develops and maintains CICL wide computer systems documentation including workstation log, server access logs, and software installation logs.

• Grant and revoke access to computer systems and secure file shares. Maintain access logs.

• Monitors and facilitates compliance with pertinent global regulatory standards including FDA 21 CFR Part 11, and GDPR.

• Develops and maintains testing and software validation documentation for CICL home grown and off-the-shelf software programs.

• BA/BS required, advance degree preferred

• Minimum of 5 years relevant experience

• Ideal candidate has at least 5 years of clinical research experience

• Ideal candidate is familiar with or has experience in SDLC, software validation, running Python script

• Knowledge of FDA regulations, ICH and GCP guidelines concerning human subject research especially as they relate to computer systems/security, disaster recovery and regulatory compliance of research core labs.

• Experience engaging vendors and operational/technical teams to buy into improvement opportunities and change implementation

• Experience working with and providing support to senior level leadership and other high-level stakeholders in a complex organization.

• A balance of patience and perseverance necessary to affect change in a large and complex organization with a strong, natural drive to get things done.

• Excellent attention to detail and a sense of responsibility for one's work.

• Strong problem-solving skills.

SKILLS/COMPETENCIES REQUIRED:

• Strong organizational skills

• Attention to detail

• Self-motivation

• Ability to perform well under pressure

• Sound decision making skills

• Strong analytical skills

SUPERVISORY RESPONSIBILITIES:

One to two direct reports. May indirectly provide leadership and guidance to less seasoned and new staff.

WORKING CONDITIONS:

The CICL supports a hybrid work environment. Employees in good standing are able to work remotely 2 days a week.