Associate Solutions Designer

Perceptive Inc.; Hyderabad; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Perceptive Inc. is seeking an Associate Solutions Designer (ASD) to support the Solutions Design team by handling operational tasks, managing simple to medium change requests, and ensuring timely completion of documentation and compliance activities.

The role leverages foundational trial process knowledge to identify risks and contribute to process improvements and readiness activities for study updates and system enhancements.

Qualifications

• Excellent interpersonal, verbal and written communication skills.
• Ability to manage multiple and varied tasks with enthusiasm.
• Experience with life sciences domain and GCP knowledge is beneficial.

Responsibilities

• Supports scoping and documentation for minor change requests and aids prioritization for more complex initiatives under supervision.
• Maintains documentation per regulatory guidelines and SOPs and keeps stakeholders updated.
• Collaborates with stakeholders to assess risk and implement mitigation strategies.
• Facilitates clear communication between cross-functional teams throughout study lifecycle.

Skills

Communication skills

Multitasking

Attention to detail

Critical thinking

Self-starter

Fast-paced environment

Education

Bachelor's Degree in technical discipline

Tools

JIRA

Job description

The Associate Solutions Designer (ASD) plays a key supporting role within the Solutions Design team. This position focuses on assisting Solutions Designers with operational tasks, managing simple to medium complexity change requests, and ensuring timely completion of documentation and compliance activities. By leveraging foundational knowledge of trial processes and system functionality, ASDs provide critical support in identifying potential risks, assisting with process improvement initiatives, and contributing to readiness activities for study updates and system enhancements.

Key Responsibilities

Requirements Definition & Management

• Supports scoping and requirements documentation for minor change requests and aids with prioritization and coordination for more complex initiatives under the guidance of Solutions Designers or Senior Solutions Designers.
• Adheres to established standards while assisting in the documentation of requirements using approved techniques and templates.
• 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.
• Works with internal stakeholders and Subject Matter Experts to identify potential risks.
• Collaborate with stakeholders to assess risk impact and likelihood and implement mitigation strategies.
• Integrate risk management practices into design documentation and decision-making processes.

Relationship Management

• Build and maintain strong working relationships with internal stakeholders, including business units, project managers, and technical teams.
• Collaborates with Solutions Designers and stakeholders to understand needs and ensure accurate documentation and alignment with proposed solutions.
• Facilitate clear and consistent communication between cross-functional teams throughout the study lifecycle.
• Manage stakeholder expectations by providing timely updates, addressing concerns, and negotiating compromises when necessary.
• Assists in resolving issues by escalating appropriately, supporting corrective actions, and helping document lessons learned and relevant information for team dissemination.
• Promote a collaborative and inclusive environment that encourages feedback and continuous improvement.
• Foster long-term partnerships by demonstrating value, reliability, and responsiveness in solution delivery.

Business Process Improvement

• Provides support in reviewing business processes and documenting opportunities for improvement, including potential use of new technologies and automation.
• Contributes to feasibility assessments for proposed process changes by gathering data and providing input to Solutions Designers.
• Supports the implementation of business process improvement tools and methods under guidance, ensuring alignment with established standards.

Other

• Carryout any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills)

• Excellent interpersonal, verbal and written communication skills
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Must have the ability to work methodically in a fast-paced, time-sensitive environment
• Demonstratable ability to apply critical thinking to problems and tasksShows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities
• A self-starter and able to work under own initiative
• Foundational knowledge of eClinical platforms
• Understanding of randomization algorithms, cohort management, and complex dosing schedules
• Familiarity with adaptive trial designs, double-blind/double-masked studies, and protocol customization
• Experience with Good Clinical Practice (GCP) and biostatistical design principles
• Knowledge of integration processes between IRT and EDC systems, including validation and risk management workflows
• Experience with global clinical trials, including working across time zones and managing diverse client expectations
• Familiarity with JIRA ticketing systems, user requirement specification templates, and SOP compliance for study builds and change requests
• Experience of working in and knowledge of the life sciences sector
• Solid professional experience in the same or very similar role
• Knowledge of and experience in Scope Management

Experience, Education, and Certifications

Bachelor's Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience