[Remote] Project Director, Evidence Development - RWE Clinical Trials

Note: The job is a remote job and is open to candidates in USA. UBC is a leader in the pharmaceutical support industry, focused on empowering health solutions and improving patient outcomes. The Project Director will provide leadership and oversight for project operations, financial performance, and client relationship management within the Evidence Development Solutions Department, ensuring successful project delivery and compliance with quality standards.

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
• Ensure development and maintenance of risk management plans and risk assessments and categorization tools
• 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
• Ensure regular conduct of formal governance discussions to assess performance and drive issue resolution
• Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance
• Ensure activities on projects are delivered with adherence to project Plans, company policies and/or sponsor’s SOPs
• Be familiar with and ensure that all projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA)
• Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior management
• Ensure that project specific tracking metrics are developed, consistent with scope of work and project timelines
• Ongoing review of available dashboards and reports for assigned projects to ensure adherence to all required activities and operational / financial performance indicators
• Assist, as directed, on specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation
• Work with UBC Business Development to develop and grow UBC client relationships and maximum business opportunities
• Attend and present at conferences as required
• 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
• Engage in cross-functional collaborations with UBC leadership staff to optimize project delivery
• Contribute to UBC meetings, training activities, and cross-functional activities as appropriate
• Partake in ongoing assessment of project delivery resource needs, manage resource requests, and allocate staff to maintain target utilizations for roles
• 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
• Identify and develop UBC process improvements
• 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
• Other duties as assigned by UBC Senior Leadership
• PD Oversight of 4 to 6 projects, depending on scope
• PD Oversight of 1 multi-study programs, depending on scope
• Direct management of 1 to 2 projects, depending on scope
• Mentor, provide support, and direct supervision of Project Managers, Associate Project Managers, Project Associates, and other administrative staff
• Conduct interviews for internal/external project management and operational candidates
• Conduct ongoing performance review of assigned staff and remediate deficiencies
• Conduct annual employee performance evaluations

Skills

• Bachelor's degree in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience
• 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
• 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
• Advanced degree (Master's or Ph.D.) preferred
• Previous history as a Project Director or Director of Clinical Operations (related) within a CRO preferred
• Broad therapeutic experience a plus

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

Company Overview

Company H1B Sponsorship