Senior EDC

About CloudLabs:CloudLabs Inc was founded in 2014 with the mission to provide exceptional IT & Business consulting services at a competitive price, to help clients realize the best value from their investments. Within a short span, CloudLabs evolved from pure-play consulting into a transformative partner for Business Acceleration Advisory, Transformative Application Development & Managed Services - enabling digital transformations, M&A transitions, Automation & Process-driven optimizations & complex Integration initiatives for enterprises across the globe. As a Strategic Planning & Implementation Partner for global companies, CloudLabs has seen a 200% uptake in winning high-value, high-impact and high-risk projects that are critical for the business. With offices in the US, Canada, & India and with the team of 200+ experienced specialists, CloudLabs is now at an inflection point and ready for its next curve of progress.Please write/follow us here:Website: cloudlabsit.comLinkedIn: CloudLabs IncEmail: Experience requirement:Minimum 5 years of relevant experience.Location:India only.Job type:Remote.Job description:We're seeking an experienced Medidata Rave/ EDC developer to support delivering strategic initiatives supporting the Global Clinical IT team. In this role, the individual will be a technical developer to support business initiatives within Medidata Rave suites of applications. This individual should have demonstrated prior experience as a member of an Agile team and be highly motivated with excellent analysis and execution skills.Duties and Responsibilities- Analyzes, designs, and develops new application software and/or interfaces between applications.- extensive knowledge on implementing Medidata Classic Rave, Rave EDC (Rave), eCOA/ePRO, iMedidata, Cloud Admin, Balance RTSM, CTMS, Coder, Grants Manager, MMI, RSR, eConsent, Safety Gateway, End of study, TSDV, Monitor tools.- Creates and maintains system documentation according to the IT methodology (code, designs, test specifications, and other deliverables as necessary) for Medidata applications (Rave, Coder, MMI, RSR, RTSM, and eConsent).- Provides production support by proactively monitoring applications and seeking to improve application availability, quality, and performance by ensuring achievement of Service Level Agreements (SLA) and participating in required on-call support, as needed.- Interacts with the business divisions to understand all data requirements to develop payments for the trials.- Defines and implements EDC solutions. Understand and perform Risk analysis on the EDC upgrade and plan accordingly for the upgrade.- Participates in all phases of the software development project including- off the shelf versus build custom analysis, design, construct, implementation, testing, and post-implementation activities.- Works closely with database teams / server team /security team on topics related to data requirements from the vendor.- ability to think outside the box and ensure has a full understanding of the request or problem to help identify a solution and willingness to lend a helping hand to support the businesses across the organization.- Develops robust systems with an eye on the long-term maintenance and support of the application.- Accountable for technical issue resolution including diagnosis of problem, recommendations for workarounds, and defect correction.- Understands agile development methodology and is familiar with working in Product Teams.- Maintains collaborative working relationship with IT business partners, IT services (database, data center, servers, desktop, networking, security), and software vendors, as needed.What we’re looking for:Basic Qualifications:- Bachelor’s degree in related field.- Experience as a developer and/or systems analyst; soliciting business requirements, story grooming, writing acceptance criteria.- Prior experience as a member of an Agile software development team- In-depth knowledge and hands-on experience in developing complex Business Rules, study structure and EDC applications (eCOA/ePRO, iMedidata, Cloud Admin, Balance RTSM, CTMS, Coder, Grants Manager, MMI, RSR, eConsent, Safety Gateway, End of study, TSDV, Monitor)- Strong written and verbal communication skills; ability to present in an organized manner to both technical and non-technical audiences.- Identify new technologies to improve the customer experience.- Must have experience integration knowledge between EDC, Veeva and Seibel CTMS- Ability to generate hi-level requirements and understanding of the business process workflow.- Experience in a Medical Device or Regulated Industry.Preferred Qualifications- Bachelor 's Degree in related field.- 5+ years of experience developing, supporting, and maintaining healthcare systems.- Prior experience with EDC system (Medidata Rave, Expert)- Prior experience with MEDS reporter, SQL- Advanced system analysis skills and experience with EDC technologies such as (iMedidata, architect modules, reporting modules).- Demonstrated experience in systems analysis, SDLC, change management, and requirements gathering.