Clinical Trials Systems Lead

About the Job

The Clinical Trials Systems Lead performs a range of activities in support of the development, implementation, training, and continuous improvement for the systems that support the execution of clinical trials at FMI by the Clinical Operations and Data Management (CODM) organization. The Clinical Trials Systems Lead will assist with project management activities, requirement gathering, system implementations, administration, test script execution, documents and procedure updates, development of training materials, user training, data cleaning, and other tasks as needed by the Clinical Trials Systems team.

This role will work closely with internal teams within FMI to support the continuous improvement of clinical trial systems.

Key Responsibilities

• Leads and participates in cross-functional system alignment meetings with internal stakeholders
• Creates and reviews project plans, meeting minutes and action items
• Supports gathering business requirements through meetings with stakeholders, documenting and tracking requests, and communicating requests to the Clinical Trials Systems team
• Supports system implementations through translating business requirements into technical requirements and providing input into system configuration and testing needs
• Collaborates with FMI technology teams and external vendors on system design and functionality improvements
• Performs system administrator tasks such as adding studies, partners, and users to systems
• Works with the Clinical Trials Systems team to develop technology roadmaps and collaborates cross-functionally with stakeholders to inform systems strategy
• Ensures information is available to support trending and reporting requirements; works with internal stakeholders to develop reports and dashboards that provide actionable data.
• Authors and executes User Acceptance Testing (UAT) and other testing as needed to support system validation
• Supports users through training, handling support requests, and acting as a resource of information
• Contributes to the development and execution of department goals and initiatives
• Participates in departmental or cross-functional projects and initiatives as assigned
• Develops and/or revises systems Standard Operating Procedures (SOPs), guidelines, and tools
• Other duties as assigned

Qualifications:

Basic Qualifications:

• Bachelor’s degree or equivalent in scientific or computer engineering field or equivalent combination of education, training, and experience
• 4 years of experience working in a field involving the management of clinical trials

Preferred Qualifications:

• 4+ years of professional work experience in the science or health industry
• 2+ years of experience working with technology
• Knowledge of Good Clinical Practice (GCP)
• Proficient in MS Office suite
• Ability to:
  • Perform assignments with minimal supervision
  • Work well under pressure while maintaining a professional demeanor
  • Prioritize and thoroughly follow up on assigned tasks
  • Handle multiple tasks at once and work in a face-paced environment
  • Adapt to changing procedures, policies, and work environment
• Expert cross-functional problem solving and collaboration mindset
• Strong organizational and planning skills; ability to complete assignments in a timely manner
• Excellent verbal and written communication skills, including email responsiveness
• Demonstrated self-starter, capable of taking ownership of tasks
• Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines
• Commitment to reflect FMI’s values:
  Integrity, Courage, Passion

The expected salary range for this position based on the primary location of Boston, MA is $80,500 – 95,000 per year. The salary range is commensurate with FMI’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for FMI benefits.

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