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1.0 - 5.0 years

0 Lacs

chennai, tamil nadu

On-site

As an Implementation Consultant reporting to the Product Owner, your key responsibilities will include creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. You will be tasked with developing wireframes and mock-ups for clinical reports, as well as communicating with Clinical Data Management & Medical Reviewers to document clinical reporting needs. It is essential that you stay up-to-date with all Saama product features and releases. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will act as a Clinical Subject Matter Expert, providing support for Clinical Project Support, authoring and documenting business requirements, and translating requirements into solutions. Additionally, you will create and maintain Data Mapping Specifications for the Saama Data Review Model. You will collaborate with customers, partners, and in-house teams to gather feedback and input on the product. As an Implementation Consultant, you will guide clients through release planning, manage communication with the team and stakeholders, lead product implementation efforts, and ensure the quality of project team deliverables. You will document and report project status and issues, identify and manage risks, and act as a client liaison to resolve outstanding issues promptly. Your responsibilities will also include ensuring a smooth transition of services from implementation to support, providing advanced analytical and reporting support to customers on various projects, and supporting configuration and quality checks with project teams. You will help identify and define new sources of relevant data, analyze data, and make recommendations. Desired skills for this role include experience in the Pharmaceutical industry, a good understanding of EDC, CTMS, IRT, and LAB Systems, proficiency in SQL, familiarity with CDASH, SDTM, and ADAM standards, and relevant degrees in Healthcare, Computer Science, or related fields. Additionally, experience as a Product Owner, familiarity with Agile Working Environment, SDLC phases, FDA regulations, and technical knowledge of Software Development and Web Development are preferred qualifications for this position.,

Posted 3 days ago

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1.0 - 5.0 years

0 Lacs

chennai, tamil nadu

On-site

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback to appropriate representatives and act to resolve outstanding issues on behalf of the client in a timely manner. Understanding the client's clinical landscape, you will provide techno-functional solutions to evolving client needs. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will create SOPs and Work instructions for the implementation/delivery team to ensure a smooth transition of services from implementation to support. Additionally, you should be able to incorporate feedback and input from customers, partners, and in-house teams on product features. Desired Skills: - Experience in the Lifesciences and Pharmaceutical industry is essential - Good experience in SQL, APIs, and Integrations - Good understanding of CDASH, SDTM, and ADAM standards - Good understanding of EDC Systems, CTMS Systems, IRT Systems, and LAB Systems - Knowledge of clinical trial domain, EDC study setup, and clinical reporting - Ability to build clinical reports and dashboards - Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - 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 - Technical knowledge including Software Development and Web Development - Experience with the use and configuration of healthcare software applications (preferably clinical),

Posted 4 days ago

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