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.com

: CloudLabs Inc

Email: info@cloudlabsit.com

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.