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Senior Process Optimization Specialist, Clinical Research Group (Evergreen)

Thermo Fisher Scientific
Thermo Fisher Scientific
2+ years
Not Disclosed
Remote, India, India
10 May 12, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Senior Optimization Specialist

Work Schedule

Standard (Monday–Friday)

Work Mode

Office-Based

Company

Thermo Fisher Scientific (PPD Clinical Research Services)


About Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in scientific and clinical research, committed to enabling customers to make the world healthier, cleaner, and safer. Through its PPD clinical research portfolio, the company supports clinical trials across 100+ countries and provides integrated solutions spanning laboratory services, digital platforms, and decentralized clinical trial capabilities.

For more information, visit: Thermo Fisher Scientific


Job Summary

We are seeking a highly experienced Senior Optimization Specialist to act as a subject matter expert in designing, developing, and improving processes, systems, and operational frameworks to enhance efficiency, compliance, and performance across clinical research functions.

The role focuses on process optimization, audit readiness, training development, and cross-functional collaboration to support high-quality global clinical trial delivery.


Key Responsibilities

Process Optimization & Improvement

  • Lead design, development, and improvement of processes, systems, and operational workflows.

  • Identify inefficiencies and implement process optimization initiatives across clinical operations.

  • Develop and refine process improvement methodologies and solutions.

  • Lead small to medium-scale continuous improvement projects.

Operational Support & Delivery

  • Collaborate with initiative leads to design and deliver departmental tools, systems, and services.

  • Support global teams in achieving operational excellence and compliance objectives.

  • Interpret complex data to support business decision-making.

Training & Documentation

  • Develop training materials, presentations, and support documentation.

  • Review and update procedural documents to ensure alignment with current processes.

  • Provide training and guidance to junior team members.

Compliance & Quality

  • Assess compliance with established processes and regulatory expectations.

  • Identify gaps in process adherence and recommend corrective actions.

  • Support audit readiness activities and quality improvement initiatives.

Stakeholder Collaboration

  • Work closely with cross-functional and globally distributed teams.

  • Support communication and coordination across departments to ensure alignment of objectives.

  • Contribute to strategic planning and execution of improvement initiatives.

Additional Responsibilities

  • Perform special projects and administrative assignments as required.

  • Support leadership in strategic initiatives and operational enhancements.


Required Qualifications

  • Bachelor’s degree or equivalent academic/vocational qualification.

  • Minimum 5+ years of relevant professional experience.

  • Significant experience in clinical research across multiple phases (start-up, conduct, close-out) preferred.


Required Skills & Competencies

Technical & Functional Skills

  • Strong understanding of clinical trial processes and procedural documentation.

  • Knowledge of clinical systems, tools, and technology platforms.

  • Understanding of regulatory guidelines and compliance frameworks.

Analytical & Problem-Solving

  • Strong analytical, investigative, and critical thinking skills.

  • Ability to interpret complex data and make informed decisions.

  • Strong risk assessment and escalation management abilities.

Communication & Collaboration

  • Excellent written and verbal communication skills in English.

  • Strong interpersonal and stakeholder management skills.

  • Ability to work in global, cross-functional, and multicultural teams.

Other Key Skills

  • Strong attention to detail and organizational ability.

  • Negotiation and influencing skills.

  • Ability to train and mentor junior team members.

  • Effective judgment and decision-making capabilities.


Working Environment

  • Office / laboratory / clinical environment.

  • Exposure to biological materials and standard laboratory conditions.

  • Use of personal protective equipment (PPE) required.

  • Work under high-pressure conditions with intense focus required.

  • Long and varied working hours may be required.

  • Occasional overnight and international travel.


Why Join This Role

  • Work with a global leader in life sciences and clinical research.

  • Contribute to improving processes across global clinical trials.

  • High-impact role influencing quality, efficiency, and compliance.

  • Opportunity to lead initiatives and mentor junior professionals.

  • Exposure to advanced clinical research systems and global operations.


Career Impact

This role offers strong growth potential into:

  • Clinical Operations Leadership

  • Process Excellence / Transformation Roles

  • Global Quality & Compliance Functions

  • Strategic Clinical Research Program Management