Clinical Project Director – EDS

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🔥 0 minutes ago

🌐 United Kingdom, Spain, +1 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇩🇪 Germany – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Provide operational leadership, oversight, and client relationship management for a broad range of UBC projects • Oversee planning, implementation, direction, and completion of project work • Direct Project Managers and cross-functional teams to deliver contracted services within timelines, budgets, and quality standards • Support business-development opportunities, including capabilities presentations, RFP review, proposals and budget input, and bid-defense participation • Provide strategic leadership, vision, and support to project teams • Drive project-manager performance, quality delivery, milestone adherence, financial-margin optimization, and customer satisfaction • Ensure project teams prepare plans aligned with contracted services and timelines • Facilitate cross-functional problem resolution and involve senior management as needed • Attend or participate in internal and external project meetings and audits • Lead and mentor multidisciplinary teams, including Project Managers, Operations teams, vendors, and functional staff • Coordinate staffing and training with cross-functional managers • Select, contract, and manage external vendors and subcontractors • Monitor project delivery against scope and budgets • Oversee budgets, resource expenditures, forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications • Identify project risks and develop mitigating strategies; maintain risk-management plans and assessments • Serve as the senior operational client contact and provide regular project updates • Conduct formal governance discussions to assess performance and resolve issues • Implement quality controls for data integrity, patient safety, and protocol compliance • Ensure compliance with project plans, company policies, sponsor SOPs, regulatory requirements, data-privacy provisions, and international guidelines • Prepare and deliver project reports, metrics, and other outputs to clients and senior management • Develop project tracking metrics and review dashboards for operational and financial performance • Develop and grow client relationships with Business Development; attend and present at conferences as required • Develop, implement, and ensure compliance with project-management processes for global projects • Lead operational strategies and process, quality, and project-delivery improvements • Collaborate with UBC leadership to optimize project delivery • Assess resource needs, manage requests, allocate staff, and implement resourcing solutions • Track staffing requirements and liaise with Human Resources on hiring and onboarding • Prepare procedures, SOPs, guidelines, and standard department materials • Ensure staff training, timesheet and expense-reporting, and required project training completion • Oversee 4–6 projects, one multi-study program, and directly manage 1–2 projects, depending on scope • Perform other duties assigned by UBC Senior Leadership

🎯 Requirements

• Bachelor's degree in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience • Minimum 12–15 years of clinical research operations experience within a CRO, pharmaceutical, device/diagnostics, or biotechnology company • Minimum 10 years of experience at increasing levels of project management or clinical research oversight responsibilities • Previous history as a Project Director or Director of Clinical Operations within a CRO preferred • Minimum 5 years of supervisory/management experience • Proven ability to lead, motivate, and manage cross-functional teams • Strong understanding and experience in operational clinical operations and overall drug/biologic development processes • Strong knowledge of functional components of clinical drug development, including clinical, data management, statistics, and medical writing • Comprehensive knowledge of ICH GCP and applicable international regulations, including EU Clinical Trials Directives and FDA Guidelines • Broad therapeutic experience a plus • Excellent understanding of and experience managing evidence development projects globally, including Phase IV studies, RWE, Phase II–III clinical trials, and expanded access programs • Ability to drive operational strategy for global evidence development programs • Experience with proposal and budget development for evidence development programs • Strong verbal, written, and interpersonal communication skills • Strong prioritization, time management, and project management skills • Strong negotiation, influencing, consensus-building, and relationship-management skills • Strong innovative, analytical, problem-solving, and decision-making skills • Strong financial acumen and budget-management experience • Strong computer skills, including MS Office • Proficiency in project-management tools and software • Demonstrated ability to manage staff to achieve company and client goals • Ability to handle multiple tasks in a fast-paced, deadline-oriented environment • 10% travel availability