Clinical Operations Manager – Budgets and Contracts

🕒 January 27

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage country deliverables, timelines, and results for assigned protocols • Ensure quality, compliance, and country commitments under ICH/GCP, country regulations, client policies, and quality standards • Oversee Clinical Trial Coordinators as applicable • Coordinate with CRMs, CRAs, CTCs, Finance, Legal, headquarters, vendors, sites, IRBs/IECs, and regulatory authorities • Oversee local processes, clinical and ancillary supplies, import/export requirements, supplies destruction, filing, archiving, retention, and insurance processes • Enter and update country information in clinical and finance systems • Deliver clinical and financial contracts within fair market value • Own country and site budgets, including development, negotiation, and completion of CTRAs • Track clinical research payments and reconciliation at study close-out • Oversee FCPA, DPS/OFAC screening, financial systems, and financial forecasting • Execute and oversee clinical trial country submissions and approvals • Develop local-language materials, informed consents, and translations • Interact with IRBs/IECs and regulatory authorities • Contribute to business initiatives, process improvement, knowledge sharing, training, mentoring, and team development • Complete required training, timesheets, expense reports, and CV updates; comply with Parexel processes and ICH-GCP requirements

🎯 Requirements

• Strong coordination and organizational skills • Skilled knowledge of budget and contract negotiations • Knowledge of local regulatory environment and submission and approval processes • Understanding of study start-up impacts • Ability to influence investigators, vendors, external partners, and country managers • Ability to make independent decisions with limited oversight • Ability to develop risk management and mitigation plans • Ability to lead a team of Clinical Trial Coordinators as applicable • Problem-solving and root-cause analysis skills • Time management, organizational, interpersonal, and conflict management skills • Strong communication, leadership, negotiation, influencing, training, and mentoring skills • Ability to manage multiple deliverables and protocols simultaneously • Ability to work effectively in a remote virtual environment • Positive and growth mindset; self-driven and capable of working independently • Ability to directly influence site staff • Excellent verbal and written influencing and training/mentoring skills in local language and English • Minimal travel required

🏖️ Benefits

• Equal opportunity employment • Minimal travel required • Remote virtual work environment