Senior Electronic Data Capture (EDC) (Medidata Rave) Designer (Remote - India)

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, Australia & India and with the team of 150+ 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

LinkedIn: CloudLabs Inc

E-Mail: info@cloudlabsit.com

What we offer:

• We welcome candidates rejoining the workforce after career break/parental leave and support their journey to reacclimatize too corporate.
• Flexible remote work.
• Competitive pay package.
• Attractive policy, medical insurance benefits, industry leading trainings.
• Opportunity to work remotely is available.

We're seeking an experienced Medidata Rave(EDC) Study Designer to support delivering strategic initiatives supporting the Global Clinical IT team. In this role, the individual will be supporting 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

• Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
• Provide subject matter expertise to project team members during all phases of project life cycle.
• Develop, test, and maintain data management systems.
• Provide subject matter expertise prior, during and post internal and external audits and inspections.
• Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data).
• Batch import agreed data sources into the EDC system.
• Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards.
• Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules.
• Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries.
• Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer).
• Conduct, test, and produce Rave EDC Migration activities as required.
• Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications.
• Coordinate and manage the deployment of new or modified EDC databases into production.
• Assist in mapping the EDC database to the company enterprise data warehouse.
• As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build processes.
• Provide input into the development and revision of department SOPs. Maintain compliance with corporate, core and study-specific learning requirements.
• Experience with Medidata Custom Functions (C#/SQL) would be preferred.

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)
• Medidata Rave EDC Certified Study Builder certification is highly preferred
• 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.

Experience requirement:

Minimum 5 years

Location:

India only.

Job type:

Remote.