Clinical Systems Leader jobs in United States
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TalentBurst, an Inc 5000 company · 16 hours ago

Clinical Systems Leader

TalentBurst, an Inc 5000 company, is looking for a Clinical Systems Leader to implement clinical systems actions for clinical trials within Early Clinical Development. The role involves collaboration with internal stakeholders and technology vendors, ensuring the successful implementation and maintenance of technology solutions supporting clinical trials.

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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Sreejith Kumar
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Responsibilities

Accountable for implementing all related clinical systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) actions for the ECD portfolio
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
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
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
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
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

Qualification

IxRS/IRTECOAClinical OperationsClinical PracticesFDA RegulationsProject ManagementVeevaCommunication SkillsTeam Collaboration

Required

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

Preferred

Experience in Veeva is a plus

Company

TalentBurst, an Inc 5000 company

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Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.

H1B Sponsorship

TalentBurst, an Inc 5000 company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (7)
2021 (1)
2020 (4)

Funding

Current Stage
Late Stage

Leadership Team

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Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
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Company data provided by crunchbase