Implementation Consultant

Description
Implementation Consultant - JD

Reports to: Product Owner

Job Description

• 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