Clinical Project Director – EDS

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Provide operational leadership, oversight, and management of client relationships for a diverse array of UBC projects.

• Supervise the planning, execution, direction, and completion of project tasks.

• Guide Project Managers and cross-functional teams to ensure that contracted services are delivered within established timelines, budgets, and quality standards.

• Assist in business development efforts, including capabilities presentations, RFP evaluations, proposal inputs, and participation in bid defenses.

• Offer strategic leadership, vision, and support to project teams.

• Enhance project-manager performance, ensuring quality delivery, adherence to milestones, financial margin optimization, and client satisfaction.

• Ensure that project teams create plans aligned with contracted services and timelines.

• Facilitate the resolution of cross-functional problems and engage senior management as necessary.

• Attend or take part in both internal and external project meetings and audits.

• Lead and mentor multidisciplinary teams, including Project Managers, Operations teams, vendors, and functional staff.

• Coordinate staffing and training efforts in collaboration with cross-functional managers.

• Select, contract, and manage external vendors and subcontractors.

• Monitor project delivery concerning scope and budget adherence.

• Oversee budget management, resource expenditures, forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications.

• Identify project risks and devise mitigation strategies; maintain risk management plans and assessments.

• Act as the senior operational client contact and provide regular updates on project status.

• Conduct formal governance discussions to evaluate performance and address issues.

• Implement quality controls to ensure data integrity, patient safety, and protocol compliance.

• Guarantee adherence to project plans, company policies, sponsor SOPs, regulatory mandates, data privacy measures, and international guidelines.

• Prepare and present project reports, metrics, and other outputs to clients and senior management.

• Develop project tracking metrics and review dashboards to assess operational and financial performance.

• Foster and enhance client relationships alongside Business Development; attend and present at conferences as necessary.

• Create, implement, and ensure compliance with project management processes for global initiatives.

• Lead operational strategies and initiatives aimed at improving processes, quality, and project delivery.

• Collaborate with UBC leadership to optimize project delivery.

• Evaluate resource needs, manage requests, allocate personnel, and implement resourcing solutions.

• Track staffing requirements and coordinate with Human Resources on hiring and onboarding processes.

• Prepare procedural documents, SOPs, guidelines, and standard departmental materials.

• Ensure staff training, completion of timesheets and expense reports, and necessary project training is fulfilled.

• Oversee 4–6 projects, one multi-study program, and directly manage 1–2 projects, based on scope.

• Carry out additional responsibilities as assigned by UBC Senior Leadership.

⛳️ Requirements

• Bachelor's degree in a relevant field (Life Sciences, Healthcare, or Business) or equivalent industry experience.

• A minimum of 12–15 years of experience in clinical research operations within a CRO, pharmaceutical, device/diagnostics, or biotechnology company.

• At least 10 years of experience in progressively responsible project management or clinical research oversight roles.

• Prior experience as a Project Director or Director of Clinical Operations within a CRO is preferred.

• Minimum of 5 years of supervisory or management experience.

• Proven capability to lead, motivate, and manage cross-functional teams.

• Strong understanding and experience in operational clinical operations and the overall processes of drug/biologic development.

• Extensive knowledge of the functional components involved in clinical drug development, including clinical, data management, statistics, and medical writing.

• In-depth knowledge of ICH GCP and relevant international regulations, such as EU Clinical Trials Directives and FDA Guidelines.

• Broad therapeutic experience is an advantage.

• Excellent understanding of and experience in managing evidence development projects globally, including Phase IV studies, RWE, Phase II–III clinical trials, and expanded access programs.

• Ability to influence operational strategy for global evidence development programs.

• Experience in proposal and budget development for evidence development initiatives.

• Strong verbal, written, and interpersonal communication abilities.

• Excellent prioritization, time management, and project management skills.

• Exceptional negotiation, influencing, consensus-building, and relationship management capabilities.

• Strong innovative, analytical, problem-solving, and decision-making skills.

• Solid financial acumen and experience in budget management.

• Proficient in computer skills, particularly MS Office.

• Familiarity with project management tools and software.

• Demonstrated ability to manage staff to achieve both company and client objectives.

• Capacity to handle multiple tasks in a fast-paced, deadline-driven environment.

• Willingness to travel up to 10% of the time.

🏝️ Benefits

• Competitive salary package.

• Comprehensive health and wellness benefits.

• Opportunities for professional growth and development.

• Collaborative and supportive work environment.