Calyx

Senior Solutions Designer

IND Hyderabad RMS 12CFull timeSeniorPosted 2 days ago
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We’re on a mission to change the future ofclinical research. At Perceptive, we help thebiopharmaceutical industry bring medicaltreatments to the market, faster.Our mission is to change the worldbut to do this, we need people like you.Apart from job satisfaction, we can offer you:HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance- Life Insurance- Critical illness coverWEALTH: - Salary structure and Flexi basket- Provident fund of 12%- Gratuity scheme YOURSELF: Internal growth and development programs & trainingsAs Senior Solutions Designer (SD), you may sit within multiple areas of the business, to facilitate the generation of value from our products and services for both internal and external customers. You will work with other levels of the SD team and multiple other stakeholders, taking ownership of substantial process improvements and initiatives.  In this role, you will be focused on translating clinical trial protocols into optimized IRT implementations that ensure accurate randomization, efficient supply management, and regulatory compliance. You will collaborate with cross-functional teams to gather requirements; design scalable solutions using various platforms and maintain meticulous documentation throughout the study lifecycle. With deep expertise in trial design and system capabilities, this role proactively identifies risks, drives process improvements, and supports go-live readiness for global clinical studies.Key ResponsibilitiesRequirements definition & managementDefines and manages scoping, requirements definition and prioritization activities for large, complex initiatives.Obtains input from, and formal agreement to, requirements from a diverse range of stakeholdersFollows agreed standards, applying appropriate techniques to elicit and document detailed requirements.Provides constructive challenge to stakeholders as required.Prioritizes requirements and documents traceability to source.Reviews requirements for errors and omissions.Provides input to the requirements baseline.Supports authorized requests for changes to base-lined requirements, in line with change management policy.Ensures all relevant documentation is maintained in accordance with relevant regulatory Guidelines and SOP’s ensuring all relevant stakeholders are updated.Risk ManagementIs able to identify and communicate risks early in the development process and implement a risk-based approach to project related decision makingWorks with internal stakeholders and Subject Matter Experts, to identify potential risks and optimal study design.Collaborate with stakeholders to assess risk impact and likelihood and propose mitigation strategies.Integrate risk management practices into design documentation and decision-making processes.Analyze and identify recurring risk patterns and trends across multiple projects to inform proactive design improvements and strategic planning.Relationship managementHelps develop and enhance clie...