Clinical Research Project Director

🕒 4 days ago

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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, 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. • Demonstrate strong oversight of financial health for assigned projects. • Proactive, ongoing identification of project risks and development of mitigating strategies. • Serve as the UBC senior operational contact with clients for all project related items. • 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.

🎯 Requirements

• 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 (related) within a CRO preferred. • Minimum 5 years 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 (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.). • Broad therapeutic experience a plus. • 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. • Experience with proposal and budget development for evidence development programs. • Client focused with strong leadership skills. • 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. • 10% travel availability.

🏖️ Benefits

• Health solutions empowerment • Inclusive workplace fostering creativity • Project leadership • Team productivity and management • Risk management • Financial oversight • Quality compliance oversight • Business development assistance • Department administration and compliance oversight