[Hiring] Project Specialist II @Parexel

Role Description

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.
• Support project oversight, progress reporting, budget control, and informed decision-making by Project Leaders and Functional Leads.
• Work independently or with minimal Line Manager oversight across all project lifecycle phases.
• Support Biotech and Enterprise projects based on business need, including project start-up and operational closeout.
• Deepen your project management expertise while helping ensure the timeliness and quality of clinical research deliverables.
• Contribute to successful clinical research delivery and the advancement of new treatments for patients.

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

• 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.

Company Description

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.