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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- Lead and drive 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.
- Responsible for leading ongoing assessment of project delivery resource needs, including management of resource requests and oversight of department allocations aligned to utilization targets.
- 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.
- Expected Project Load: PD Oversight of 6 to 8 projects, depending on scope.
- PD Oversight of up to 2 multi-study programs, 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.
Requirements
What you’ll need- 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 15-20 years of clinical research operations experience, within in a CRO, pharmaceutical, device/diagnostics or biotechnology company
- Minimum 15 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 8 years supervisory/management experience
- Proven ability to lead, motivate, and manage cross-functional teams.
- Deep 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
- Proven understanding of methodological, scientific, and operational aspects related to the planning and execution of evidence development and RWE programs (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 in pricing/proposal models for evidence development programs and application to staffing requirements.
- Client focused with enhanced leadership skills
- Excellent verbal, written, and interpersonal communication skills
- Excellent prioritization, time management, and project management skills
- Excellent negotiation, influencing, consensus building, and relationship management skills
- Excellent innovative, analytical, problem-solving and decision-making skills
- Excellent financial acumen and budget management experience.
- Excellent 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
Comp & perks- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match
- Tuition reimbursement (after 90 days of employment)
- 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 (after 90 days of employment)
- Long-term disability
- Life insurance
- Discount programs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Project ManagementClinical Drug DevelopmentRisk ManagementFinancial AcumenData ManagementStatistical AnalysisMedical WritingEvidence Development ProgramsProposal DevelopmentResource Allocation
Soft Skills
LeadershipCommunicationProblem-SolvingNegotiationTime Management
