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Project Specialist I

2+ years
Not Disclosed
10 Nov. 13, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Project Specialist I

Company: Parexel
Location: India (Remote)
Job Type: Full-time
#LI-REMOTE


Overview

As part of Parexel’s Global Project Leadership group, the Project Specialist I supports cross-functional teams in delivering high-quality, patient-focused clinical trials. The role involves project planning, execution, reporting, and collaboration with both internal teams and clients to ensure timely, efficient, and compliant project delivery.

You will play an integral role in helping bring life-changing treatments to market faster, while working in a supportive and empowering environment that encourages professional growth and diverse learning opportunities.


Key Accountabilities

1. Project Management

  • Assist in the setup and maintenance of project management plans with input from the Project Leader.

  • Maintain selected data in the integrated project management system and ensure compliance across project systems.

  • Generate project reports, metrics, and compliance data for internal and client reviews.

  • Perform initial analysis of project and financial data; coordinate corrections as required.

  • Collaborate with Project Leaders and Functional Leads to develop and track action plans to completion.

  • Oversee project team lists, system access, and periodic reviews.


2. Project Initiation Management

  • Customize systems, tools, and project plans per SOPs.

  • Support vendor selection and create project-specific training curricula.

  • Review time bookings, pass-through costs, and analyze resource utilization.

  • Coordinate with TMF Lead, IPO, and eCBL for Trial Master File (TMF) and site payment setup.

  • Ensure timely resource allocation and tracking of insurances and Letters of Authorization.


3. Project Execution & Control

  • Analyze study reports to identify issues and maintain SOP-compliant systems.

  • Support integrated project planning, communication, and coordination among functions.

  • Review time bookings, training compliance, and cost management with Functional Leads.

  • Assist in preparing and following up Project Operational Review meetings.

  • Provide data-driven insights and reports for decision-making and risk management.


4. Project Meeting Management

  • Prepare for and attend internal and client meetings.

  • Present updates and track assigned action items.

  • Support documentation and follow-up of meeting outcomes.


5. Project Vendor Management

  • Collaborate with Project Leaders and Functional Leads to ensure timely study supply deliveries as per contracts.

  • Perform vendor invoice reviews to ensure accuracy and compliance.


6. Project Closure Management

  • Execute project closeout activities using defined checklists.

  • Coordinate system closure, document archiving, and sponsor handovers.

  • Support financial closeout documentation and review.


7. SME / Mentorship (If Assigned)

  • Train and mentor new Project Specialists in Parexel systems and tools.

  • Provide feedback and suggestions to improve processes and technologies.


Competency Levels

Competency

Level

Project Management

Proficient

Financial Management

Proficient

Analytical Mindset

Proficient

Quality Delivery

Advanced

Team-Oriented Approach

Advanced

Ownership

Advanced

Communication

Advanced

Client Focus

Proficient

Risk Management

Basic


Required Skills

  • Excellent interpersonal, verbal, and written communication skills.

  • Strong attention to detail and understanding of quality impact.

  • Client-focused and adaptable approach to assignments.

  • Ability to manage multiple tasks, prioritize effectively, and adjust to changes.

  • Analytical problem-solving and critical thinking abilities.

  • Comfortable working in a matrix and team-oriented environment.


Knowledge & Experience

  • 1+ year experience as a Project Specialist, or 2+ years in Clinical Research.

  • Strong understanding of cross-functional project roles and deliverables.

  • Experience working in global, multi-regional teams.

  • Familiarity with ICH/GCP guidelines.


Education

  • Minimum: Bachelor’s degree or equivalent in Life Sciences or related field.

  • Language: Intermediate to Advanced English proficiency (for non-native speakers).


Why Work at Parexel

  • Empowered to take ownership of your projects and career path.

  • Work with diverse clients and therapeutic areas.

  • Supportive culture that values collaboration, innovation, and patient focus.

  • Opportunities for career progression within the global Project Leadership group.