Clinical Research Project Director

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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 strategic leadership, vision, and support to the project teams, ensuring alignment with the company's goals and client expectations. • Drive PM performance, project quality delivery, milestone timeline adherence, financial margin optimization, and customer satisfaction through efficient and effective directorship. • Ensure project teams prepare project plans to meet contracted services and timelines. • Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, ensuring effective communication, collaboration, and performance of project deliverables according to contract terms. • Select, contract, and manage external vendors and subcontractors, when necessary, while maintaining quality and cost-effectiveness. • Monitor delivery of projects per scope and budgets, and demonstrate strong oversight of financial health for assigned projects. • Proactive, ongoing identification of project risks and development of mitigating strategies to minimize their impact on projects effectively. • Serve as the UBC senior operational contact with clients for all project related items, maintaining strong relationships, addressing their needs, and providing regular project updates. • Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance. • Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior management. • Assist, as directed, on specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation. • Lead, innovate, and develop operational strategies that meet requirements and maximize project delivery success. • Identify and develop UBC process improvements. • Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources.

🎯 Requirements

• Bachelor's degree in in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience • Minimum 12 – 15 years of clinical research operations experience, within in 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 (related) within a CRO preferred • Minimum 5 years supervisory/management experience • Strong understanding and experience in operational clinical operations and overall drug/biologic development processes • Strong knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and medical writing) • Comprehensive knowledge of ICH GCP and applicable international regulations (EU Clinical Trials Directives, FDA Guidelines, etc.) • Excellent understanding of and experience managing evidence development projects (e.g., Phase IV studies, RWE, Ph II – III clinical trials, expanded access programs, etc.) globally • Ability to drive operational strategy for global evidence development programs.

🏖️ Benefits

• 10% travel availability • Flexibility to work in a remote environment • Opportunity to engage in cross-functional collaborations