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Project Specialist Ii

2-3 years
Not Disclosed
10 Sept. 23, 2025
Job Description
Job Type: 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 II

Primary Location: India (Remote)
Work Mode: Remote
Company: Parexel


Overview

As part of Parexel’s global Project Leadership group, the Project Specialist II leads cross-functional teams to deliver high-quality, patient-focused clinical trials. This role involves collaboration with clients and internal stakeholders to manage project plans, timelines, budgets, and operational metrics. The position requires strong leadership, communication, analytical, and problem-solving skills, along with the ability to work in a matrix environment.


Success Profile / Key Traits

  • Adaptable

  • Communicator

  • Collaborative

  • Leadership-oriented

  • Proactive

  • Problem-solver


Key Responsibilities

1. Project Management

  • Set up and maintain Project Management Plans with Project Leader (PL) input.

  • Maintain selected information in integrated project management systems and ensure compliance with project data requirements.

  • Prepare project reports, compliance metrics, and operational data for client and internal oversight.

  • Review financial areas and coordinate with stakeholders for required corrections.

  • Collaborate with PL and Functional Leads (FLs) on action plans and track completion.

  • Oversight of project team lists, system access, and reviews.

2. Project Initiation Management

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

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

  • Analyze time booking and overconsumption for review.

  • Coordinate project resources in line with project scope.

  • Collect, distribute, and track insurances and Letters of Authorization.

3. Project Execution and Control

  • Study reporting, issue highlighting, and maintenance of systems/tools per SOPs.

  • Ensure coherent project management plans, integrating activities across functions.

  • Support Project Operational Review meetings and provide metrics for informed decision-making.

  • Monitor project system accesses and provide delegated oversight if required.

4. Project Meeting Management

  • Prepare and attend project meetings.

  • Support preparation of materials for internal and client meetings.

  • Track and follow up on action items.

5. Project Vendor Management

  • Collaborate with PL and FLs to ensure study supplies meet contract obligations.

  • Perform vendor invoice reviews.

6. Project Closure Management

  • Execute close-out responsibilities using the close-out checklist.

  • Ensure systems closure, document archiving, and sponsor handover.

  • Support financial close-out preparation.

7. SME / Mentorship (if assigned)

  • Train and mentor new starters on systems and tools.

  • Provide feedback to enhance CRS technology tools and processes.


Competency Levels (per PPS Competency Guide)

  • Project Management: Proficient

  • Financial Management: Proficient

  • Analytical Mindset: Proficient

  • Quality Delivery: Advanced

  • Team-Oriented Approach: Advanced

  • Ownership: Advanced

  • Communication: Advanced

  • Client-Focused Approach: Proficient

  • Risk Management: Basic


Skills

  • Strong interpersonal, verbal, and written communication skills.

  • Attention to detail and understanding impact on business outcomes.

  • Client-focused and flexible attitude toward assignments.

  • Ability to manage multiple tasks and prioritize workload.

  • Teamwork in a matrix environment.

  • Advanced problem-solving and analytical thinking skills.


Knowledge & Experience

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

  • Understanding of how the role integrates with others to accomplish project objectives.

  • Experience working globally across regions.

  • Knowledge of ICH/GCP guidelines.


Education

  • Minimum Bachelor’s degree or equivalent.

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


Application

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