Project Director, Evidence Development – Clinical Operations CRO

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.
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