FSP Program Lead – Data Management

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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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

• Directly manage FSP Clinical Operations managers and staff and oversee Client accounts • Support FSP Clinical Operations business objectives and ensure on-time, high-quality deliverables • Resource Client projects with qualified staff and retain and develop employees • Participate in project bids and Client presentations to promote new business • Execute and oversee Program Management activities for one or more programs • Serve as a point of contact between Senior Management and key Client personnel • Plan and manage logistics, infrastructure, and resources for FSP services • Collaborate with Clients to implement short- and long-term strategies • Develop and manage communication and escalation plans • Oversee Client governance, performance management, KPIs, meetings, and contractual requirements • Manage issue escalation and resolution, including CAPA development when necessary • Coordinate hiring, selection, onboarding, offboarding, and resource planning • Lead, manage, coach, mentor, and conduct performance reviews for direct reports • Provide technical support and oversee staff training and compliance • Collaborate with Training, Quality, Contracts, Recruiting, Finance, Human Resources, Clients, and other functions • Serve as a subject matter expert during audits and inspections • Identify and implement process improvements and participate in SOP and industry initiatives • Create business proposals, RFIs, and RFPs • Maintain productivity, billability, staff turnover, departmental metrics, and administrative compliance • Establish FSP solutions and market positioning for prospective and existing Clients • Develop and maintain Client work orders and service orders • Manage Client relationships and standardization initiatives across clinical trial processes • Ensure contracted services meet time, quality, cost, and regulatory requirements

🎯 Requirements

• Minimum 5+ years of FSP Clinical Operations experience in a CRO setting • Minimum 3 years of previous line management experience • Direct experience with FSP Program Leadership in the Data Management function • Direct experience with FSP resourcing projections, billing, and financial tracking • Experience with workforce forecasting, billing processes, and financial tracking in an FSP context • In-depth knowledge of drug development and clinical trial operations • Comprehensive understanding of local regulations, including FDA and EMA, and ICH/GCP guidelines • Experience applying regional and country-specific talent acquisition, labor practices, retention strategies, and cultural differences • Experience working remotely and independently managing remote staff in a matrix organization • Experience in customer service/FSP outsourcing models and resource allocation forecasting • Exceptional written and verbal communication, interpersonal, persuasion, negotiation, and conflict moderation skills • Ability to interact effectively with all management levels and organizational functions • Demonstrated leadership and ability to manage and motivate direct reports and wider teams • Ability to manage multiple programs, projects, and tasks and prioritize effectively • Planning, observation, analytical, problem-solving, judgment, and decision-making skills • Self-motivated, detail-oriented, and flexible • Strong computer skills, including Microsoft Excel, Word, and PowerPoint • Proficiency in written and spoken English • Degree-level education in biological science, pharmacy, or another health-related discipline, or equivalent nursing qualification or relevant clinical equivalent experience

🏖️ Benefits

• Professional development opportunities • Staff training and soft skills development • Opportunities for career development and management pipeline development • Remote work environment • Global and cross-functional collaboration • Travel as needed