Project Specialist

Parexel International; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending Accounts

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is a leading global clinical development partner delivering insights‑driven clinical and consulting solutions to the life sciences industry. We are seeking a Project Specialist II to join our team in a remote capacity based on the East Coast, developing and maintaining project plans, reports, and governance across lifecycle phases.

You will deepen your project management expertise while ensuring timeliness and quality of clinical research deliverables, with growth opportunities across

Qualifications

• Bachelor’s degree or equivalent required.
• At least 1 year as Project Specialist or 2+ years in Clinical Research.
• ICH / GCP knowledge is required.
• Experience working across regions worldwide is preferred.
• Excellent oral and written communication skills.

Responsibilities

• Develop, customize, and maintain Project Management Plans with input from Project Leader and Functional Lead per SOPs.
• Provide project reports, compliance metrics, financial information, and analysis for review and reporting.
• Maintain information, systems, tools, project team lists, and reviews in the PM environment.
• Collaborate with Project Leaders on action plans, resources, and follow-ups.
• Support project initiation activities including vendor selection and training curricula.
• Prepare for and attend project meetings and report on owned responsibilities.
• Collaborate to ensure study supplies are delivered and review vendor invoices.
• Lead operational closeout activities and support financial closeout preparation.
• Support CTMS compliance and tracking of site, shipment, lab, and other reports.

Skills

Project management

Financial management

Analytical thinking

Quality delivery

Ownership

Communication

Education

Bachelor's degree

Tools

CTMS

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights‑driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient‑focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry‑leading innovation, With Heart®.

About the Role

Project Specialist II

We are seeking a Project Specialist II to join our team in a remote capacity based on the East Coast. As a Project Specialist II, you will develop and maintain project plans, provide project-level reports and metrics, and support project oversight, progress reporting, budget control, and informed decision-making by Project Leaders and Functional Leads. Working independently or with minimal Line Manager oversight across all project lifecycle phases, you may support Biotech and Enterprise projects based on business need, including project start‑up and operational closeout. This role offers the opportunity to deepen your project management expertise while helping ensure the timeliness and quality of clinical research deliverables.

You’ll join a fast‑paced, growth‑oriented environment where your work supports effective study execution through coordinated planning, meaningful analysis, and consistent follow‑through. By helping project teams maintain quality, compliance, financial oversight, and operational readiness, Project Specialist II contributes to successful clinical research delivery and the advancement of new treatments for patients. With diverse teams and continuous learning opportunities, you can expand your skills across project management, financial management, systems, and global clinical research operations.

Key Responsibilities

• Develop, customize, and maintain coherent Project Management Plans with Project Leader and Functional Lead input in accordance with applicable SOPs.
• Provide project reports, compliance metrics, financial information, and analysis to support operational review, client and internal reporting, project oversight, risk management, and Project Leader decision‑making.
• Maintain selected information, systems, tools, project team lists, system access records, and required reviews within the integrated project management environment.
• Collaborate with Project Leaders and Functional Leads on action plans, resource requests, project activities, and follow‑up with the project team on action items.
• Support project initiation activities, including vendor selection, project‑specific training curriculum, time‑booking review, pass‑through cost review, TMF and site payment set‑up, system access management, insurance tracking, and Letters of Authorization.
• Prepare for and attend project meetings, support information preparation for internal and client meetings, report on owned responsibilities, and track and follow up on action items.
• Collaborate with Project Leaders and Functional Leads to help ensure study supplies are delivered as required and in accordance with contractual obligations, and perform vendor invoice review.
• Lead assigned operational closeout activities using the closeout checklist, coordinating with functions to close systems, archive documents, hand over final work to the sponsor, and support financial closeout preparation.
• Support the Clinical Operations Leader with CTMS compliance and the tracking and analysis of site, shipment, laboratory, contact, closure, vendor, query, and other assigned reports.

Candidate Profile

You’ll thrive in this role if you bring:

• Strengths in project management, financial management, analytical thinking, quality delivery, ownership, and communication
• Professional interpersonal, verbal, and written communication skills
• Strong attention to detail and an understanding of how the quality of your work impacts others and business outcomes
• The ability to prioritize and manage multiple varied tasks, adapt to change, and learn quickly
• A client‑focused, team‑oriented approach and willingness to work in a matrix environment

Required Qualifications

• Minimum Bachelor’s degree or equivalent degree
• Minimum one year of experience in the Project Specialist role or more than 2 years of experience in Clinical Research
• ICH / GCP knowledge
• Experience working globally across regions
• Excellent oral and written communication skills

Preferred Qualifications

• Proficiency in project management and financial management
• Advanced quality delivery, ownership, communication, and professionalism
• Advanced problem‑solving skills and the ability to apply analytical thinking to resolve issues
• Understands how the role connects with business partners to achieve project deliverables and area objectives

Benefits and Compensation

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.