Senior Solutions Designer

Posted 16 Hours Ago
Be an Early Applicant
Hyderabad, Telangana, IND
In-Office
Senior level
Healthtech • Biotech
The Role
Translate clinical trial protocols into optimized IRT implementations, define and manage requirements, identify and mitigate risks, collaborate with cross-functional teams and vendors, ensure regulatory compliance and documentation, drive process improvements, support system validation and go-live readiness for global clinical studies.
Summary Generated by Built In

We’re on a mission to change the future of
clinical research. At Perceptive, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but 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 cover

WEALTH:

- Salary structure and Flexi basket

- Provident fund of 12%

- Gratuity scheme

YOURSELF: Internal growth and development programs & trainings

As 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 Responsibilities

Requirements definition & management

  • Defines 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 stakeholders

  • Follows 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 Management

  • Is able to identify and communicate risks early in the development process and implement a risk-based approach to project related decision making

  • Works 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 management

  • Helps develop and enhance client and stakeholder relationships, and is able to influence customers, suppliers and partners

  • Build and maintain strong working relationships with internal stakeholders, including business units, project managers, and technical teams.

  • Act as a trusted advisor to stakeholders by understanding their needs and translating them into effective solution designs.

  • Facilitate clear and consistent communication between cross-functional teams throughout the study lifecycle.

  • Collaborate with external vendors and partners to ensure alignment with solution requirements.

  • Manage stakeholder expectations by providing timely updates, addressing concerns, and negotiating compromises when necessary.

  • Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information.

  • 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

  • Contributes to the definition of organizational policies, standards, and guidelines for business process improvement

  • Assists with analyzing and designing business processes, identifying alternative solutions to exploit new technologies and automation.

  • Assists in assessing the feasibility of business process changes and recommends new approaches.

  • Assists to select, tailor and implement business process improvement methods and tools at program, project and team level in line with agreed standards.

Other

  • Carryout any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills)

  • Demonstrates deep understanding of IRT platforms.

  • Familiarity with adaptive trial designs, double-blind/double-masked studies, and protocol customization.

  • Ability to demonstrate a strong grasp of Good Clinical Practice (GCP) and biostatistical design principles.

  • Demonstrable knowledge of integration processes between IRT and EDC systems, including validation and risk management workflows.

  • Demonstrates understanding of working in and leading in an Agile environment (Scrum, Kanban).

  • Familiarity with JIRA ticketing systems, user requirement specification templates, and SOP compliance for study builds and change requests.

  • Demonstrable knowledge of in Scope Management.

  • Knowledge of and ability to undertake thorough Root Cause Analysis.

  • 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 tasks.

  • Shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities.

  • Ability to identify and implement process improvements.

  • Proactively participates in skills improvement training and encourages their teams to participate.

  • A self-starter and able to work under own initiative.

  • Maintains an up-to-date awareness of trends, tools, technology, techniques and processes that affect technology within the Life sciences domain.

Experience, Education, and Certifications

  • Experience using tools to communicate progress to Stakeholders.

  • Experience of regulated environments (GxP, Financial, etc…).

  • Expertise in randomization algorithms, cohort management, and complex dosing schedules.

  • Proven track record of designing and building studies across all phases and therapeutic areas (e.g., oncology, ophthalmology, allergy) preferred.

  • Experience with global clinical trials, including working across time zones and managing diverse client expectations.

  • Demonstrable hands-on involvement in specification development, system validation, and go-live support.

  • Proven experience of working in and knowledge of clinical development in the life sciences industry.  

  • Solid professional experience in the same or very similar role.

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

  • English: Fluent.

Come as you are.

We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Skills Required

  • Deep understanding of IRT platforms
  • Knowledge of integration processes between IRT and EDC systems, including validation and risk management workflows
  • Familiarity with adaptive trial designs, double-blind/double-masked studies, and protocol customization
  • Strong grasp of Good Clinical Practice (GCP) and biostatistical design principles
  • Expertise in randomization algorithms, cohort management, and complex dosing schedules
  • Experience in regulated environments (GxP, Financial, etc.)
  • Proven hands-on involvement in specification development, system validation, and go-live support
  • Solid professional experience in the same or very similar role
  • Experience using tools to communicate progress to stakeholders
  • Familiarity with Agile environments (Scrum, Kanban)
  • Familiarity with JIRA ticketing systems and user requirement specification templates
  • Knowledge of scope management and ability to perform root cause analysis
  • Bachelor's Degree in a technical discipline or equivalent project-related experience
  • English fluency
  • Proven track record of designing and building studies across phases and therapeutic areas
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
5,000 Employees

What We Do

Expanding on their combined 50-year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing. Perceptive’s offerings include imaging biomarkers and core lab services, as well as innovative technologies in randomization and trial supply management (RTSM), analytics, and software.

Similar Jobs

Wells Fargo Logo Wells Fargo

Consultant

Fintech • Financial Services
Hybrid
Hyderabad, Telangana, IND
205000 Employees

Wells Fargo Logo Wells Fargo

Lead Operations Processor

Fintech • Financial Services
Hybrid
Hyderabad, Telangana, IND
205000 Employees

Wells Fargo Logo Wells Fargo

Security Engineer

Fintech • Financial Services
Hybrid
Hyderabad, Telangana, IND
205000 Employees

Wells Fargo Logo Wells Fargo

Consultant

Fintech • Financial Services
Hybrid
Hyderabad, Telangana, IND
205000 Employees

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account