Worldwide Clinical Trials · 7 hours ago
Senior Manager, Clinical Applications - U.S. - Remote
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expWorldwide Clinical Trials is a global, midsize CRO dedicated to improving lives through innovative approaches. The Senior Manager, Clinical Applications will oversee application management plans, ensure compliance with regulatory standards, and lead data governance initiatives within the clinical portfolio.
Health CarePharmaceutical
Responsibilities
Develop, implement, and oversee functional Application management plans for the portfolio of systems
Manage and document application, system, and performance controls in line with industry best practices
Manage application operations activities and staff; monitor, review, investigate, and escalate system support events in technical areas relating to application performance
Develop, implement, and maintain functional metrics such as KPIs and QTLs, inclusive of Uptime, System/Capability Utilization
Form partnerships with Business Owners and IT Infrastructure to ensure Enterprise class support is given to these business-critical systems
Partner with Computer Systems Validation and Technical Delivery to ensure that validation and regulatory documentation is completed to ensure compliance with GxP standards
Work with Worldwide business clients to document business requirements for projects and applications interfaced with it
Lead Data Governance across team ensuring appropriate rigor and discipline is present across data integration, mastering, and management for all systems within the clinical portfolio
Perform system configuration and functional testing ensuring it meets requirements and specifications
Partner with Technical Delivery to Write and review validation scripts and user acceptance testing for new workflows and processes
Provides technical expertise and training to teammates and business users
Work with project teams and users to resolve or escalate technical issues
Estimate and plan implementation activities
Work with software vendors to understand and support existing and future functionality
Co-ordinate system Disaster Recovery (DR) testing as required
Write, review, and update Standard Operating Procedures, Work Instructions and Business Guidelines for both IT technicians and end users
Qualification
Required
Strong planning and scheduling skills
Excellent written and verbal communication skills
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Ability to exercise sound judgment and make decisions independently
Must be self-motivated and able to work with minimal supervision
Able to succeed and contribute to a team environment
Proficiency in MS-Office and cloud-based systems and applications
General Knowledge in HIPAA, data privacy and security, GxP, and FDA regulations governing validated applications, 21CFR Part 11 and ICH E6 (R2) Good Clinical Practice
A proven track record in setting expectations, providing feedback, and guiding professional growth ensures both organizational goals and individual aspirations are achieved
Bachelor's degree preferably in a technical discipline
Minimum of 8 years' experience managing application performance, health, and availability or equivalent experience
Demonstrated expertise in people leadership includes inspiring, coaching, and developing diverse teams, while effectively managing team dynamics, resolving conflicts, and recognizing individual strengths for optimal performance
Familiar with databases like Oracle or SQL Server
Knowledge of Quality Assurance functions
Experience in the pharma, CRO, or other health-related industry
Company
Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO that provides preclinical and Phase I-IV clinical development services to pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Worldwide Clinical Trials 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
2024 (1)
2023 (5)
2022 (3)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2023-08-07Acquired
Leadership Team
Rosemarie Corrigan
Executive Vice President, Global Quality
Robyn Greener
Associate Director, Project Management
Recent News
2025-12-18
EIN Presswire
2025-11-19
2025-09-22
Company data provided by crunchbase