Job Summary:We are looking for an experienced Implementation Consultant to support the successful product deployments in the pharmaceutical and clinical trial domain. The ideal candidate will have a deep understanding of clinical trial processes, EDC/CTMS/IRT systems, and data management, ensuring seamless implementation, configuration, and support for customers.
Key Responsibilities:Product & Process Expertise- Stay up-to-date with all clinical product features and releases.
- Analyze and understand current business processes, events, and data flows.
- Understand the impact of process changes and align them with business requirements.
- Act as a Clinical Subject Matter Expert (SME), providing guidance to project teams.
- Write and document business requirements, translating them into functional solutions.
Implementation & Client Engagement- Lead client engagements to guide them through release planning and implementation efforts.
- Manage communication across internal teams, stakeholders, and customers.
- Ensure high-quality project deliverables, tracking status, risks, and issues.
- Oversee data mapping specifications for Saama Data Review Models.
- Act as a client liaison, collecting feedback and ensuring timely issue resolution.
- Support User Acceptance Testing (UAT), assisting in configuration changes and issue triaging.
- Ensure a smooth transition from implementation to support.
Analytics & Reporting- Provide advanced analytical and reporting support for various projects.
- Identify and define new sources of relevant clinical data for integration.
- Conduct data analysis and provide actionable recommendations.
- Support configuration quality checks to ensure solutions meet business objectives.
Required / Must-Have Skills:- Experience in the pharmaceutical industry is essential.
- Strong knowledge of one or more clinical systems, including:
- EDC Systems (e.g., Medidata Rave, Veeva EDC, Oracle Clinical, Medrio, InForm).
- CTMS Systems (e.g., Siebel CTMS, Medidata CTMS, Veeva CTMS).
- IRT Systems (e.g., YPRIME, Parexel ClinPhone).
- Lab Systems (e.g., Central Labs, Local Labs).
- Good understanding of clinical trial processes, EDC study setup, and reporting workflows.
- Bachelor's or master's degree in healthcare, Computer Science, Engineering, or a related field.
- 3-5 years of experience as a Product Manager or 1-2 years as a Product Owner.
- Experience working in an Agile environment.
Good-to-Have Skills:- Familiarity with Software Development Life Cycle (SDLC).
- Understanding of FDA regulations (21 CFR Part 11, GxP).
- Experience working on multiple product life cycles.
- Technical knowledge of software development and web-based applications.
- Experience with healthcare software applications, particularly clinical systems.
Why Join Us?- Work on cutting-edge clinical data and analytics solutions.
- Collaborate with a highly skilled pharmaceutical and clinical research team.
- Competitive salary, career growth opportunities, and exposure to leading life sciences technologies.
If you are passionate about clinical data, implementation, and digital transformation, we encourage you to apply.