Patients First. Powered by Evidence.
Project Director, Evidence Development – Clinical Operations CRO
Location
United States
Posted
2 days ago
Salary
0
Seniority
Lead
Job Description
Project Director, Evidence Development – Clinical Operations CRO
UBC
• 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 • 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 and collaborate with UBC Business Development to develop and grow UBC client relationships and maximize business opportunities • 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 • Identify, develop, and implement improvements to UBC processes, quality, and overall project delivery • Contribute to UBC meetings, training activities, and cross-functional activities as appropriate • Implement creative resourcing solutions to maximize productivity and utilization of the team • Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources • Prepare procedures, SOPs, guidelines and other standard materials for department • Ensure staff are adequately trained on applicable SOPs, processes, and systems • Ensure timely completion of timesheets and expense reporting by assigned staff • Ensure timely completion of required UBC and project specific training by assigned staff
Job 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 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.)
- 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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