Clinical Systems Leader

Fusion Life Sciences Technologies ( ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors.

What sets us apart is our AI-powered, in-house software s enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.

Job Title :
Clinical Systems Leader

Duration : 1+yr contract

Location :
South San Francisco CA

Working Model:
Hybrid (three days in office, two remote) - Anchor Days are Tuesday through Thursday

Interview Format:
Two rounds (1 - virtual; 2 in-person)

The Clinical Systems Leader (CSL) is responsible for implementing all
Related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD). The CSL collaborates with a cross-functional team of internal stakeholders and technology vendors to ensure the successful implementation and maintenance of technology solutions supporting clinical trials.

Primary Responsibilities:

• Study Execution and System Management:
  Accountable for implementing all related clinical systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) actions for the ECD portfolio.
• Project Management:
  Closely manage study-related timelines and associated activities. Manage and lead the end-to-end specifications for the build of clinical systems for an assigned study or enterprise project. This includes requirements review, testing, deployment, maintenance, enhancement, and closeout.
• Technical Oversight:
  Provide technical oversight to ensure that clinical systems solutions (e.g.,IxRS/eCOA) adhere to the study protocol, industry regulations/best practices, and company policies, procedures, and guidelines.
• Collaboration and Teamwork:
  Work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Trial Leader, Biostatistician, Drug Supply Chain, Data Management functions, and Procurement) and technology vendors. Work independently with PET stakeholders and/or cross-functional project teams with little to no oversight. Works collaboratively with the ECD I&A team to share knowledge.
• Issue and
  
  Risk Management:
  
  Proactively identify and track study-level technical issues to resolution. Ensure prompt resolution of system issues, document issues and risks, and implement mitigation plans in partnership with the study team and technology vendor project manager.
• Communication & Presentation
  
  Skills:
  
  Strong verbal and written communication skills; strong business presentation skills;
  Able to explain technical issues and communicate clearly, concisely, and professionally with internal, external stakeholders and departmental leadership.

Who You Are:

• Bachelor s Degree in life science, computer science, engineering, information system, data science or related discipline
• 2-5 years of experience in Clinical Operations, or Clinical Systems Management
• 2-5 years of IxRS/IRT and clinical-related systems experience
• Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, and eCOA
• Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
• Excellent written and verbal communication skills and strong project management skills
• Familiar with documentation in a regulated environment. Experience in Veeva is a plus

All your information will be kept confidential according to EEO guidelines.