Implementation Consultant

This role is for an Implementation Consultant responsible for creating URS and functional requirements for Clinical Reporting and Analytics, including wire-frames and mock-ups. The consultant will communicate with Clinical Data Management and Medical Reviewers to document reporting needs, analyze business processes in Clinical Trial Development, and act as a Clinical Subject Matter Expert. Key responsibilities include authoring business requirements, providing analytical support, managing project implementation, and ensuring smooth service transition. The role requires strong analytical skills, problem-solving, and support for UAT and configuration.

Must Have

• Create URS and functional requirement specs in Clinical Reporting and Analytics
• Create wire-frames and mock-ups for Clinical reports
• Communicate with Clinical Data Management & Medical Reviewers and document clinical reporting needs
• Analyze and understand current business processes, events and flows in Clinical Trial Development
• Provide Clinical Project Support and act as a Clinical Subject Matter Expert
• Author and document business requirements and provide analytical support
• Create and maintain Data Mapping Specifications for Saama Data Review Model
• Manage all aspects of projects related to implementation
• Ensure a smooth transition of services from implementation to support
• Provide advanced analytical and reporting support to customers
• Solve complex problems and conduct complex analysis
• Support configuration and quality check with project teams
• Identify and define new sources of relevant data, analyze data, and make recommendations
• Support customer UAT phase for any configuration change or issue triaging
• Experience in the Pharmaceutical industry is essential
• Good understanding of Clinical Systems (EDC, CTMS, IRT, LAB)
• Good experience in SQL
• Good understanding of clinical trial domain & overall EDC study setup & Clinical reporting
• Good understanding and experience in building Clinical reports and dashboards
• Good understanding of CDASH, SDTM and ADAM standards
• Comfortable and familiar with the Agile Working Environment
• Experience working with all phases of SDLC
• Experience working in the complete product life cycle of two or more products
• Technical knowledge including Software Development and Web Development
• Experience with use and configuration of healthcare software applications

Good to Have

• Familiarity with FDA regulations such as 21 CFR Part 11 and GxP

Description

Implementation Consultant - JD

Reports to: Product Owner

Key Responsibilities

• Responsible for creating URS and functional requirement specs in Clinical Reporting and Analytics
• Create wire-frames and mock-ups for Clinical reports
• Responsible for communicating with Clinical Data Management & Medical Reviewers and document the clinical reporting needs.
• Should be up-to-date with all the Saama product features and releases.
• Should analyze and understand current business processes, events and flows in Clinical Trial Development
• Should be responsible for Clinical Project Support and acts as a Clinical Subject Matter Expert
• Responsible for authoring and documenting business requirements and providing analytical support and expertise needed to translate requirements into solutions.
• Should be able to create and maintain Data Mapping Specifications for Saama Data Review Model.
• Should incorporate feedback and input from customers, partners and in-house teams on product
• Should manage and assume accountability for all aspects of projects related to implementation including:
• Guiding the client through release planning in support of the overall project.
• Managing communication throughout the team and stakeholders. Lead product implementation efforts coordinating with customers, product SME and other teams
• Managing the quality of project team deliverables.
• Documenting and reporting status and issues.
• Identifying, reporting and managing risks; overcoming project obstacles.
• Acting as a client liaison and representative communicating client feedback to appropriate representatives; acting to resolve outstanding issues on behalf of client in a timely manner.
• Should ensure a smooth transition of services from implementation to support.
• Should provide advanced analytical and reporting support to customers on various projects. Solves complex problems and / or conducts complex analysis.
• Should support configuration and quality check with project teams to ensure solution will meet the business objectives of the requirements.
• Should be able to help identify and define new sources of relevant data, Analyzing data and make recommendation.
• Should support customer UAT phase for any configuration change or issue triaging.
• Should understand and can discuss the application and implications of changes to process, and relation to requirements.

Desired Skills

• Experience in the Pharmaceutical industry is essential
• Good understanding of one or more of the following Clinical Systems
• EDC Systems such as Medidata Rave, Veeva EDC, Oracle InForm, etc.,
• CTMS Systems such as Siebel CTMS, Medidata CTMS,Veeva CTMS, etc.,
• IRT Systems such as YPRIME, Parexel Clinphone, etc.,
• LAB Systems such as central Lab, local Labs etc.,
• Good experience in SQL
• Good understanding of clinical trial domain & overall EDC study setup & Clinical reporting
• Good understanding and experience in building Clinical reports and dashboards
• Good understanding of CDASH, SDTM and ADAM standards.
• Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - Bachelor's degree (BA) in computer science, or equivalent work experience required.
• 3-5 years of experience as a Product Manager or 1-2 years of experience as a Product Owner.
• Comfortable and familiar with the Agile Working Environment.
• Experience working with all phases of SDLC
• Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus
• Experience working in the complete product life cycle of two or more products.
• Should have technical knowledge that includes knowledge of Software Development and Web Development.
• Experience with use and configuration of healthcare software applications (preferably clinical)