Project Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, tailor, and sustain Project Management Plans in alignment with relevant SOPs.

• Generate project reports, compliance metrics, financial data, and analyses for operational assessments, reporting, oversight, risk management, and decision-making processes.

• Manage project information, systems, tools, project team rosters, system access records, and necessary reviews.

• Collaborate on action plans, resource requests, project activities, and follow up on action items.

• Assist with project initiation tasks, including vendor selection, training, time-booking review, pass-through cost evaluation, TMF and site payment setup, system access, insurance tracking, and Letters of Authorization.

• Prepare for and participate in project meetings; gather information, report on responsibilities, and track action items.

• Ensure timely delivery of study supplies in accordance with requirements and contractual obligations; evaluate vendor invoices.

• Oversee assigned operational closeout activities, including system closures, document archiving, sponsor handover, and financial closeout preparations.

• Aid in CTMS compliance and the tracking and analysis of site, shipment, laboratory, contact, closure, vendor, query, and other reports.

⛳️ Requirements

• A minimum of a Bachelor’s degree or an equivalent qualification.

• At least one year of experience in the Project Specialist position or over two years in Clinical Research.

• Knowledge of ICH / GCP standards.

• Experience collaborating globally across different regions.

• Exceptional oral and written communication abilities.

• Proficiencies in project management, financial oversight, analytical reasoning, quality delivery, ownership, and effective communication.

• Strong interpersonal, verbal, and written communication skills.

• Keen attention to detail.

• Capability to prioritize and manage multiple diverse tasks, adapt to changes, and learn rapidly.

• Client-focused, team-oriented mindset with a willingness to thrive in a matrix environment.

🏝️ 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.

• Paid time off.

• Life insurance.

• Additional benefit offerings in accordance with applicable plans.