
Clinical Project Director – EDS
Posted Aug 26

Posted Aug 26
This is a fully remote position, open to applicants in United Kingdom, +2 more countries.
• Participate in and execute activities related to project operations, financial results, business growth, and departmental administration within the UBC Evidence Development Solutions Department.
• Provide operational leadership, oversight, and manage client relationships for UBC projects.
• Supervise the planning, implementation, direction, and completion of project tasks.
• Direct Project Managers and cross-functional teams to ensure that contracted services are delivered on schedule, within budget, and to quality standards.
• Assist in business development opportunities and lead or engage in departmental process initiatives.
• Offer strategic leadership, vision, and support to project teams.
• Enhance project management performance, quality delivery, milestone adherence, financial margin optimization, and client satisfaction.
• Ensure project teams develop project plans that align with contracted services and timelines.
• Engage in cross-functional interactions to meet project needs and facilitate problem resolution.
• Attend or participate in internal and external project meetings and audits as necessary.
• Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff.
• Collaborate with cross-functional managers to ensure sufficient project staffing and training.
• Select, contract, and manage external vendors and subcontractors when required.
• Monitor project delivery against scope and budgets while overseeing project financial health.
• Manage project budgets, resource expenditures, forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications.
• Identify project risks and create mitigation strategies; maintain risk management plans and assessments.
• Serve as the senior operational client contact and offer regular project updates.
• Conduct formal governance discussions to evaluate performance and resolve issues.
• Implement quality controls for data integrity, patient safety, and protocol compliance.
• Ensure compliance with project plans, company policies, sponsor SOPs, regulatory requirements, data privacy provisions, and international guidelines.
• Prepare and present 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 contributions, and bid defense participation.
• Cultivate client relationships, maximize business opportunities, and attend or present at conferences as necessary.
• Develop, implement, and ensure compliance with project management processes for global projects.
• Lead operational strategies and implement enhancements 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 innovative resourcing solutions.
• Track staffing requirements and coordinate with Human Resources regarding strategy, hiring, and onboarding.
• Prepare procedures, SOPs, guidelines, and standard departmental materials.
• Ensure timely completion of staff training, timesheet and expense reporting, and required project training.
• Oversee 4–6 projects, 1 multi-study program, and directly manage 1–2 projects, depending on scope.
• Perform additional duties as assigned by UBC Senior Leadership.
• Bachelor's degree in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience.
• Advanced degree (Master's or Ph.D.) is preferred.
• At least 12–15 years of clinical research operations experience within a CRO, pharmaceutical, device/diagnostics, or biotechnology company.
• A minimum of 10 years of progressively responsible project management or clinical research oversight experience.
• Previous experience as a Project Director or Director of Clinical Operations within a CRO is preferred.
• Minimum of 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.
• In-depth knowledge of the functional components of clinical drug development, including clinical, data management, statistics, and medical writing.
• Comprehensive understanding of ICH GCP and applicable international regulations, including EU Clinical Trials Directives and FDA Guidelines.
• Broad therapeutic experience is 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 strategies for global evidence development programs.
• Experience in proposal and budget development for evidence development programs.
• Strong verbal, written, and interpersonal communication skills.
• Excellent prioritization, time management, and project management abilities.
• Strong negotiation, influencing, consensus building, and relationship management skills.
• Strong innovative, analytical, problem-solving, and decision-making capabilities.
• Strong financial acumen and budget management experience.
• Proficient computer skills, including MS Office.
• Familiarity with project management tools and software.
• Results-driven and team-oriented, with the ability to influence outcomes as needed.
• Demonstrated ability to manage staff to achieve company and client goals.
• Capability to handle multiple tasks in a fast-paced, deadline-driven environment.
• 10% travel availability.
BeOne Medicines
ICF
NUC University
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