eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

You will make an impact:

As the Principal Implementation Consultant - Central Monitoring, you will be responsible for partnering with our clients to translate their quality oversight goals to a well-defined, holistic RBQM implementation strategy. You will liaise with our clients and internal stakeholders to align our client’s RBQM strategy to the RBQM module and other functionality within elluminate. You will be a savvy pharmaceutical/biotech/CRO professional with advanced experience in the handling, cleansing or analysis of clinical data and is well-versed in RBM/RBQM processes, roles, industry guidance, and methodologies. You will have excellent organization skills and are a creative solution-oriented individual. You will have experience with software implementation and exhibit prowess with data review and cleaning tools including those that support clinical data reporting, analytics and most specifically, RBM and RBQM.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Your day to day:

• Participate in elluminate RBQM implementations by providing RBQM business process and product best practice consulting services
• Collaborate with customers to establish a RACT process, and/or translate RACT process/dialogue to elluminate
• Develop a reusable library of process, resource, and best practice documentation to support client implementation of RBQM

• Collaborate with customers to define KRIs/QTLs
• Provide efficient and effective RBQM implementation services for clients, by ensuring appropriate requirements gathering through sound assessment of the clients’ quality oversight goals, and system expectations
• Consult in a post-implementation capacity to measure and drive increase in the ROI customers receive from elluminate
• Steer productive elluminate implementation workshops through a consultative process, and provide high-quality support
• Collaborate with technical, engineering, product and project management team members to develop new/enhanced product offerings in alignment with client objectives

• Configure elluminate software to meet the client requirements
• Support elluminate training team in preparation of RBQM course materials
• Assist sales effort to drive new sales by delivering RBQM Proofs of Concept, Prototypes/Pilots and targeted presentations that fulfill client expectations
• Collaborate with Marketing to develop RBQM client specific case studies and share client success
• Other duties as assigned

Take the first step towards your dream career. Here is what we are looking for in this role.

Qualifications:

• Four-year college degree or higher preferred, analytic discipline a plus and/or equivalent work experience
• Well versed in ICH E6 (R2) guidance
• Experience in a software development environment a plus
• 10+ years of experience in Pharmaceutical/Biotechnology/CRO with a minimum of 5+ years of experience in RBM/RBQM role
• Experience contributing to, and/or leading RACT dialogue

• Experience defining KRIs/QTLs
• Excellent knowledge of the drug development process and clinical trial execution as they relate to data collection, management, and analytics and reporting.
• Ability to think logically to solve complex problems
• Excellent verbal and written communication skills, organizational and time management skills
• Solid understanding of database concepts and ability to use data to optimize reporting, data mapping and programming

• Solid analytical and technical skills and experience with analytic software applications (i.e. Spotfire, J-Review, Qlik, Tableau, CluePoints, Cyntegrity)
• Prior management and delivery of technical projects in a professional services environment is a plus
• Self-motivating, able to assume responsibility and work autonomously in a professional manner
• Proficiency in Microsoft Office Applications, specifically MS Project Excel, Visio, PowerPoint, Word
• Proficiency with clinical data review, analytics, and RBQM solutions required

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.