Project Director, Evidence Development – Clinical Operations CRO
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Job Description
Project Director overseeing clinical operations projects at UBC. Leading project teams, managing client relationships, and ensuring adherence to quality and timelines.
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, Ph 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.
Benefits:
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
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