Implementation Consultant

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