Clinical Project Director – EDS

🕒 il y a 19 jours

🌐 Royaume-Uni, Espagne, +1 autres pays – Distant

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⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of UBC

UBC

1001 - 5000 employés

Fondée en 2003

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

UBC est une entreprise dédiée à l'amélioration des résultats pour les patients en reliant les thérapies spécialisées aux patients dans le besoin. Elle offre des solutions modernes et personnalisées axées sur l'accès, la sécurité, et la génération de preuves pour les produits biopharmaceutiques. UBC se spécialise dans le développement de preuves, la gestion des risques, et l'accès des patients, en utilisant des données du monde réel et des technologies innovantes pour optimiser le parcours de soins et assurer l'utilisation efficace des médicaments.

Description

• Engage in and deliver activities related to project operations, financial performance, business development, and department administration within the UBC Evidence Development Solutions Department • Provide operational leadership, oversight, and client relationship management for UBC projects • Oversee planning, implementation, direction, and completion of project work • Direct Project Managers and cross-functional teams to ensure contracted services are delivered within timelines, budgets, and quality standards • Support business development opportunities and lead or participate in departmental process initiatives • Provide strategic leadership, vision, and support to project teams • Drive project management performance, quality delivery, milestone adherence, financial margin optimization, and customer satisfaction • Ensure project teams prepare project plans aligned with contracted services and timelines • Engage in cross-functional interactions to address project needs and drive problem resolution • Attend or participate in internal and external project meetings and audits as needed • Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff • Work with cross-functional managers to ensure adequate project staffing and training • Select, contract, and manage external vendors and subcontractors when necessary • Monitor project delivery against scope and budgets and oversee project financial health • Oversee project 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 adherence to project plans, company policies, sponsor SOPs, regulatory requirements, data privacy provisions, and international guidelines • Prepare and deliver project progress reports, metrics, and other outputs to clients and senior management • Develop project tracking metrics and review dashboards and reports for operational and financial performance • Assist with capabilities presentations, RFP reviews, proposals, budget input, and bid defense participation • Develop client relationships, maximize business opportunities, and attend or present at conferences as required • Develop, implement, and ensure compliance with project management processes for global projects • Lead operational strategies and implement improvements to UBC processes, quality, and project delivery • Collaborate with UBC leadership and contribute to meetings, training, and cross-functional activities • Assess resource needs, manage resource requests, allocate staff, and implement creative resourcing solutions • Track staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding • Prepare procedures, SOPs, guidelines, and standard department materials • Ensure staff training, timesheet and expense reporting, and required project training are completed on time • Oversee 4–6 projects, 1 multi-study program, and directly manage 1–2 projects, depending on scope • Perform other duties assigned by UBC Senior Leadership

🎯 Exigences

• Bachelor's degree in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience • Advanced degree (Master's or Ph.D.) preferred • 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, including Phase IV studies, RWE, Phase II–III clinical trials, and expanded access programs, globally • 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 • Results driven and team-oriented, with the ability to influence outcomes as necessary • Demonstrated ability to manage staff to achieve company and client goals • Ability to handle multiple tasks in a fast-paced, deadline-oriented environment

🏖️ Avantages

• 10% travel availability

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