Project Director, Evidence Development – Clinical Operations CRO

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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 • Engage in UBC cross-functional interactions to address project needs and drive problem resolution; facilitate the involvement of Senior Management as necessary • Attend/participate in project internal / external meetings, and audits as needed • 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 • Oversee project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications • 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 and collaborate with UBC Business Development to develop and grow UBC client relationships and maximize business opportunities • Responsible for the development, implementation, and project management process compliance for global projects • Lead, innovate, and develop operational strategies that meet requirements and maximize project delivery success • Identify, develop, and implement improvements to UBC processes, quality, and overall project delivery • Contribute to UBC meetings, training activities, and cross-functional activities as appropriate • Implement creative resourcing solutions to maximize productivity and utilization of the team • Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources • Prepare procedures, SOPs, guidelines and other standard materials for department • Ensure staff are adequately trained on applicable SOPs, processes, and systems • Ensure timely completion of timesheets and expense reporting by assigned staff • Ensure timely completion of required UBC and project specific training by assigned staff

🎯 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 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 • 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.) • 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

• Competitive salaries • Growth opportunities for promotion • 401K with company match* • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs