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.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
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