Clinical Applications Program Lead jobs in United States
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Integra LifeSciences · 1 day ago

Clinical Applications Program Lead

Integra LifeSciences is focused on innovating new treatment pathways to advance patient outcomes. The Clinical Applications Program Lead will contribute to the development and improvement of clinical applications while ensuring they meet business objectives and user needs. This role involves managing training programs, supporting performance metrics, and maintaining validation documentation for clinical systems.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Contributes to process improvements specific to the development, implementation, and continued improvement of clinical applications. Interfaces with users/stakeholders to ensure clinical applications meet business objectives and requirements. Assists in developing business cases to include technology recommendations and cost justification to secure project funding
Approaches clinical applications with a holistic view, solving complex problems to achieve interoperability across technology platforms. Applies knowledge of software development best practices ensuring that the design and usability of clinical applications adhere to established policies, procedures, and standards
In collaboration with Clinical Operations Management, supports the facilitation, identification, and capture of meaningful and actionable metrics to continuously evaluate performance and promote data driven decision making. Drives utilization through the building of technology/dashboards that ensure transparency of information across the organization
Manages the creation and implementation of effective training programs for internal and external stakeholders to enable users to leverage the full extent of the technology. Works with Clinical Operations functions to help implement clinical application best practice, standardization, utilization and optimization to help improve departmental efficiency. Actively works to promote end user adoption, acceptance and active user community dialogue
Leads the maintenance of all required system and study level (as applicable) system validation documentation. Ensures a comprehensive and well documented risk-based approach is taken to system change control; validation documentation is compiled, archived and “audit ready” for all system upgrades, enhancements, patches, etc. Identifies, evaluates, plans and coordinates the release of system patches, upgrades, and fixes, minimizing disruption to the end user base

Qualification

Clinical management systemsSoftware development lifecycleRegulated industry experienceRelational databasesIT networking principlesMedical device regulationsCommunication skillsProblem-solving skillsTeam collaboration

Required

Education: BA / BS computer science/information technology or life sciences from a 4 year accredited university or college with an understanding of relational databases, thorough knowledge of IT networking and security principles, and knowledge of software development lifecycle models in a regulated environment
Experience: Minimum three (3) to five (5) years professional experience supporting software development and maintenance within a regulated industry
Thorough knowledge of clinical management and information system (i.e., Veeva CTMS, eTMF, CDMS) usage in the Medical Device, Pharmaceutical, Biotech or CRO industry
Thorough knowledge of medical device industry regulations including 21 CFR Part 11 and ICH/GCP guidelines, clinical development, and clinical trial principles

Benefits

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))

Company

Integra LifeSciences

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Integra LifeSciences is an integrated medical device company.

H1B Sponsorship

Integra LifeSciences 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 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)

Funding

Current Stage
Public Company
Total Funding
$350M
2018-05-15Post Ipo Equity· $350M
1995-08-25IPO

Leadership Team

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Mojdeh Poul
Chief Executive Officer
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Lea Knight
EVP and Chief Financial Officer
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Company data provided by crunchbase