Principal Clinical Applications Specialist
Job Description SummaryThe Principal Clinical Application Specialist (CAS) is responsible for the continued development, support, maintenance, training and promotion of end user adoption of some specific Clinical Applications managed by Global Clinical Development (GCD). He/She will ensure the Clinical Applications will enable business process, drive efficiency, and promote best practice across GCD, Business Units and Countries. He/She will serve as an expert in some specific Clinical Applications and as such may be called upon to perform the
responsibilities of the functional areas that they support.
Essential Job Functions:
- Leads analysis of organizational needs for development and implementation of clinical applications; interfaces with users to ensure that clinical applications are deployed which meet their business objectives and requirements.
- Provides input into the development of clinical application standards, policies, and procedures.
- Ensures that the design and use of clinical applications adhere to established policies, procedures, and standards.
- Works with GCD, Business Units and Countries to implement clinical application best practice, standardization, utilization and optimization to help improve departmental efficiency.
- Ensures effective training programs for internal and external stakeholders to enable users to leverage the full extent of the technology.
- Approaches Clinical Applications with a holistic view and strives for interoperability across the technology platform.
- Provides timely and expert level support and troubleshooting of issues impacting Clinical Applications.
- Contributes to solutions for routine technical problems and liaises with software vendors, hosting partners, IT and GIS as appropriate to resolve issues.
- Maintains all required system and study level (as applicable) documentation.
- Provide mentoring and/or management of other members of the department as assigned by the Manager, Clinical Information Systems.
- 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.
- In collaboration with the Manager of Clinical Analytics and/or GCD Management, facilitates the identification and capture of meaningful and actionable metrics to continuously evaluate performance and promote data driven decision making.
- Through the use of technology/dashboards ensures transparency of information across the organization.
- Performs user account management activities.
- Identifies, evaluates, plans and coordinates the release of system patches, upgrades and fixes, minimizing disruption to the end user base.
- Delivers clear and concise communication of planned and unplanned disruptions in service to affected end users.
- Continuously works to identify areas for process improvement and feature enhancement.
- Actively works to promote end user adoption, acceptance and active user community dialogue.
- Develop business case to include technology recommendations and cost justification to secure project funding.
- BA/BS computer science/information technology or life sciences from a 4 year accredited university or an equivalent combination of education, industry related experience, and performance may be considered.
- Minimum 5 years managing clinical information systems (CDMS and/or CTMS).
- Expert level proficiency in CDMS and/or CTMS.
- Highly independent worker, self-motivated and accountable for managing multiple projects concurrently.
- Demonstrates leadership abilities to provide peer training.
- Expert level understanding of relational databases.
- Advanced proficiency with MS Word, Excel and PowerPoint.
- Experience and comfort in working both independently and as part of a multifunctional team.
- Excellent interpersonal skills, strong written and verbal communication skills.
- Intermediate working knowledge of clinical development.
- Intermediate working understanding of techniques of clinical trial principles.
- Ability to interact effectively within and across team environment.
- Intermediate knowledge of IT networking and security principles.
- Advanced knowledge of software development lifecycle (SDLC) models and methodologies in a regulated environment.
- Intermediate knowledge of industry regulations including 21 CFR Part 11 and ICH/GCP guidelines.
- Ability to travel up to 10% of the time.
Additional Desirable Qualifications, Skills and Knowledge:
- Experience with reporting and/or business intelligence tool desired.
- PL/SQL, SQL scripting highly desired.
- Knowledge of Oracle Clinical CDMS desired.
- Knowledge of BioClinica Express CTMS desired.
- Knowledge of computer programming languages highly desired.
- Basic understanding of SAS desired.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
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