
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.
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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.
• Lead creation and execution of exploratory and biopharmaceutics clinical development plans at the molecule level • Provide technical leadership and operational oversight of clinical research trials • Plan and deliver clinical trial and submission milestones on time and on budget throughout the molecule lifecycle • Oversee global clinical trial operations from design through execution • Create and manage timelines, outsourcing plans, vendor management, operational deliverables, and budgets • Provide scientific and therapeutic-area expertise for Phase 1 clinical asset strategies • Consult on protocols, Investigator Brochures, risk profiles, annual reports, briefing documents, NDAs, safety updates, CSRs, abstracts, publications, and manuscripts • Lead implementation and integration of clinical project management processes and tools • Work with Third Party Organizations to execute clinical strategy and oversee key trial deliverables • Maintain clinical plan timelines and process maps and communicate progress to the molecule team • Develop and manage the overall clinical budget and change-control process • Identify and communicate clinical risks and mitigation or contingency plans • Oversee clinical trial operations and delivery of project milestones • Select and manage vendors and oversee their operational deliverables • Serve as the global clinical team point of contact for implementation issues, risk assessments, contingency planning, and communication • Partner with regulatory and medical teams on safety management and monitoring processes • Document decisions, actions, scope, resources, timelines, and clinical metrics; ensure appropriate archiving • Manage partnerships and integration with the clinical team, including governance forums • Communicate information across organizational levels to support decision-making • Collaborate across a matrix organization and deliver through others • Coach and provide constructive feedback to colleagues • For select roles: recruit, develop, retain, train, mentor, and manage department personnel; support talent, succession, performance, workload, and resource planning
• Bachelor’s degree in a science related field from an accredited college or university • 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies; 5+ years preferred • Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials • Ability to influence and oversee Third Party Organizations (TPOs) to enable delivery of trial-level deliverables • Demonstrated knowledge and experience with project management tools and processes • Demonstrated ability to work effectively cross-culturally and in a virtual work environment • Demonstrated ability to influence internal and external environments and forge strong working relationships • Demonstrated problem-solving skills, including root-cause diagnosis and corrective action • Strong self-management, organizational, interpersonal, leadership, and networking skills • Flexibility in varying environments and with multiple customer groups • Excellent oral and written communication skills • Strong computer skills; proficiency with Word, Excel, PowerPoint, and Microsoft Project • Ability to travel, up to 10% • Advanced scientific degree preferred • Exploratory and biopharmaceutics clinical development experience preferred • Vendor management and contracting experience • Proven experience coaching and mentoring others • Demonstrated high-level end-user computer skills
• No specific benefits, perks, or compensation extras are stated in the posting
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