Clinical Systems Leader

Clinical Systems Leader ROCGJP00026006

A leading biotechnology company is seeking a Clinical Systems Leader. The successful candidate will be responsible for leading the support of clinical systems that are used in the development of the clinical trials in ECD (Early Clinical Development). The ideal candidate has 7+ years of experience in clinical operations, clinical supply chain or clinical systems management.

Clinical Systems Leader Pay and Benefits:

• Hourly pay: $110-$120/hr
• Worksite: Leading biotechnology company (South San Francisco, CA 94080)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 12 Month Assignment

Clinical Systems Leader Responsibilities:

• Responsible for guiding, planning, and implementing all IxRS/IRT actions for ECD portfolio.
• Work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Lead, Biostatistician, Drug Supply Chain, Data Management functions, and Procurement) and technology vendors to support the implementation and maintenance of interactive response technology solutions to support clinical trials.
• Provide technical oversight to ensure that IxRS/IRT or other clinical system solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
• Lead and facilitate system requirements gathering meetings with clinical study teams and IxRS/IRT or other clinical system vendor contacts.
• Lead and responsible for the project management in all aspects, from specification, development, user acceptance testing, implementation, training, and amendments, to closeout.
• Closely manage project-related timelines and associated activities. Proactively identify and track portfolio/study-related technical issues to resolution. Document issues and risks, and implement mitigation plans in partnership with study team and technology vendor project manager.

Clinical Systems Leader Qualifications:

• 7+ years of experience in clinical operations, clinical supply chain or clinical systems management.
  
• 5+ years of IxRS/IRT and clinical-related systems experience.
• Bachelor's Degree in life science, computer science, engineering, information systems, data science or related discipline.
• Experience in Veeva is a plus.
• 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.
• Detail-oriented and able to manage many projects simultaneously.
• Good negotiation skills.
• Familiar with documentation in a regulated environment.
• Excellent documentation and communication skills.
• Meeting management and facilitation skills across multiple line functions.
• Solid vendor management experience.
• Excellent project management and organization skills in a timeline-driven environment.
• Sound problem-resolution, judgment, and decision-making abilities.