Clinical Project Director – EDS
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Job Description
Clinical Project Director leading global evidence-development programs at UBC Evidence Development Solutions. Overseeing clinical research operations, project finances, quality, clients, and cross-functional teams.
Responsibilities:
- Engage in and deliver activities related to project operations, financial performance, business development, and department administration within the UBC Evidence Development Solutions Department
- Provide operational leadership, oversight, and client relationship management for UBC projects
- Oversee planning, implementation, direction, and completion of project work
- Direct Project Managers and cross-functional teams to ensure contracted services are delivered within timelines, budgets, and quality standards
- Support business development opportunities and lead or participate in departmental process initiatives
- Provide strategic leadership, vision, and support to project teams
- Drive project management performance, quality delivery, milestone adherence, financial margin optimization, and customer satisfaction
- Ensure project teams prepare project plans aligned with contracted services and timelines
- Engage in cross-functional interactions to address project needs and drive problem resolution
- Attend or participate in internal and external project meetings and audits as needed
- Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff
- Work with cross-functional managers to ensure adequate project staffing and training
- Select, contract, and manage external vendors and subcontractors when necessary
- Monitor project delivery against scope and budgets and oversee project financial health
- Oversee project budgets, resource expenditures, forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications
- Identify project risks and develop mitigating strategies; maintain risk management plans and assessments
- Serve as the senior operational client contact and provide regular project updates
- Conduct formal governance discussions to assess performance and resolve issues
- Implement quality controls for data integrity, patient safety, and protocol compliance
- Ensure adherence to project plans, company policies, sponsor SOPs, regulatory requirements, data privacy provisions, and international guidelines
- Prepare and deliver project progress reports, metrics, and other outputs to clients and senior management
- Develop project tracking metrics and review dashboards and reports for operational and financial performance
- Assist with capabilities presentations, RFP reviews, proposals, budget input, and bid defense participation
- Develop client relationships, maximize business opportunities, and attend or present at conferences as required
- Develop, implement, and ensure compliance with project management processes for global projects
- Lead operational strategies and implement improvements to UBC processes, quality, and project delivery
- Collaborate with UBC leadership and contribute to meetings, training, and cross-functional activities
- Assess resource needs, manage resource requests, allocate staff, and implement creative resourcing solutions
- Track staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding
- Prepare procedures, SOPs, guidelines, and standard department materials
- Ensure staff training, timesheet and expense reporting, and required project training are completed on time
- Oversee 4–6 projects, 1 multi-study program, and directly manage 1–2 projects, depending on scope
- Perform other duties assigned by UBC Senior Leadership
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 within a CRO preferred
- Minimum 5 years of 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, including clinical, data management, statistics, and medical writing
- Comprehensive knowledge of ICH GCP and applicable international regulations, including EU Clinical Trials Directives and FDA Guidelines
- Broad therapeutic experience a plus
- Excellent understanding of and experience managing evidence development projects, including Phase IV studies, RWE, Phase II–III clinical trials, and expanded access programs, globally
- Ability to drive operational strategy for global evidence development programs
- Experience with proposal and budget development for evidence development programs
- 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
Benefits:
- 10% travel availability
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