Senior Manager, Clinical Applications

Worldwide Clinical Trials•Durham, NC

67d

About The Position

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Information Technology Department does at Worldwide The IT department is made up of seasoned professionals united in one common goal: to keep Worldwide’s technical infrastructure operating at the highest levels for our employees and our customers. We are a global team comprised of numerous professionals including cyber security, artificial intelligence, IT helpdesk, application support, and more.

Requirements

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.

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