Project Director, Evidence Development – Clinical Operations CRO

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Responsibilities • 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. • Work with cross‑functional managers to ensure projects are adequately staffed; team members receive adequate training for specific job assignments. • 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: capabilities presentations, RFP review, proposals/budget input, bid defence participation. • 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.

Requirements • Bachelor's degree in 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.). • Broad therapeutic experience a plus. • Excellent understanding of and experience managing evidence development projects (e.g., Phase IV studies, RWE, Phase 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.