Instagram
youtube
Facebook

Project Specialist I

1-2 years
Not Disclosed
10 Nov. 26, 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

Location: India (Remote)
Employment Type: Full-Time
Company: Parexel

Overview

Parexel is seeking a detail-oriented and proactive Project Specialist I to support the successful delivery of global clinical trials. As part of the Project Leadership group, you will assist cross-functional teams in planning, tracking, and executing high-quality clinical studies that contribute to accelerating the availability of life-changing treatments. This role provides the opportunity to work remotely while collaborating with global teams, clients, and therapeutic experts.

Parexel offers a supportive environment that emphasizes accountability, empowerment, and career development, with exposure to diverse projects and therapeutic areas.


Key Responsibilities

Project Planning and Set-Up

  • Support Project Leaders in developing and maintaining project management plans.

  • Update and manage data within the integrated project management system and ensure compliance across functions.

  • Prepare project reports, operational review metrics, and initial data analyses.

  • Review financial data and follow up with relevant stakeholders for corrections.

  • Coordinate with Functional Leads to track action plans through completion.

  • Maintain project team lists, system access permissions, and related documentation.

Project Initiation

  • Customize project tools, systems, and plans in alignment with SOPs.

  • Support vendor selection processes and document verification.

  • Set up project-specific training curricula and monitor time booking, pass-through costs, and resource allocation.

  • Collaborate with TMF Leads, IPO, and eCBL to ensure proper TMF and system setup.

  • Manage insurance documentation and Letters of Authorization tracking.

Project Execution and Control

  • Support study reporting, issue identification, and data-driven insights for project teams.

  • Maintain compliance of systems and tools throughout the study lifecycle.

  • Manage project integration activities, including communication plans and coordinated execution across functions.

  • Review training compliance and follow up on deviations.

  • Assist with preparation and follow-up of Project Operational Review meetings.

  • Provide project metrics, analytical summaries, and risk management insights.

Project Meeting Support

  • Prepare documentation and attend internal and client meetings.

  • Present updates on assigned responsibilities.

  • Track action items and coordinate timely follow-up.

Vendor Coordination

  • Work with Project Leaders and Functional Leads to ensure timely delivery of study supplies.

  • Assist with vendor invoice review and contract adherence monitoring.

Project Closure

  • Execute close-out activities using standardized checklists.

  • Support the closure of systems, archiving of documents, and final deliverables to sponsors.

  • Assist in financial close-out activities.

Training and Mentorship (If Assigned)

  • Train and mentor new hires in tools and systems.

  • Provide user feedback to enhance tools and processes.


Required Skills and Competencies

  • Strong verbal and written communication skills.

  • High attention to detail and commitment to quality delivery.

  • Ability to manage multiple priorities and adapt to changing demands.

  • Skilled in analytical thinking and complex problem-solving.

  • Strong teamwork and stakeholder collaboration abilities.

  • Client-focused mindset with ability to work in a matrix environment.

  • Proficiency in reviewing data and preparing operational reports.

Competency Levels

  • Project Management: Proficient

  • Financial Management: Proficient

  • Analytical Mindset: Proficient

  • Quality Delivery: Advanced

  • Team Collaboration: Advanced

  • Ownership and Accountability: Advanced

  • Communication: Advanced

  • Client Focus: Proficient

  • Risk Management: Basic


Experience Requirements

  • Minimum 1 year of experience as a Project Specialist within clinical research, or

  • Minimum 2 years of experience in a clinical research environment.

  • Good understanding of cross-functional collaboration within clinical projects.

  • Experience working with global teams across regions.

  • Knowledge of ICH-GCP guidelines.


Education

  • Bachelor’s degree or equivalent in life sciences or related field.

  • Intermediate to advanced English proficiency for non-native speakers.


Additional Information

  • Remote work flexibility is available for candidates based in India.

  • This position is classified under #LI-REMOTE.