Project Manager leading Phase I - IV clinical trials for global CRO Worldwide Clinical Trials. Coordinating teams, resources, deliverables, and regulatory - compliant execution.
About the role
- Director leading clinical trial project management at Everest, a full-service CRO serving pharmaceutical, biotechnology, and medical device industries. Overseeing portfolios, teams, budgets, timelines, and regulatory-quality delivery.
Responsibilities
- Oversee project planning, communication, and execution of clinical research and development services
- Plan and implement new client service delivery requests within the client portfolio
- Support existing client portfolios with holistic biometrics and full-service project deliveries across clinical development programs
- Align functional area directors’ and managers’ efforts in project planning, task and deliverable identification, and resource assessment
- Track project and portfolio performance using strategic planning and project tracking methods and tools
- Conduct project progress reviews and facilitate Everest and client governance meetings
- Ensure projects meet quality, operational, and financial budget standards
- Support solution and budget development for complex projects and scopes
- Provide leadership, training, mentorship, and management oversight to project management staff
- Review project management applicants and recommend candidates for interview processing
- Develop project management policies, standard operating procedures, governing documents, and work instructions
- Drive departmental process and technology improvement initiatives
- Develop reusable project management templates and training materials
- Identify project issues and bring risks and solutions to functional area leadership
- Collaborate with functional leaders to ensure successful project startup, continuation, and completion
- Interact with clients on strategic partnership governance, portfolio planning, performance metrics, opportunities, and resource projections
- Manage project management aspects of assigned Phase I–IV clinical trials according to applicable guidelines and regulations
- Lead cross-functional project teams
- Manage project planning, implementation, conduct, and reporting within timelines, budgets, quality standards, and regulatory requirements
- Track project tasks, hours, budgets, financial status, and expenses; escalate major deviation risks
- Facilitate problem solving and conflict resolution as a senior escalation resource
- Conduct lessons-learned meetings
- Contribute to staff performance evaluations
- Assist with RFIs and RFPs, bid defense meetings, work scopes, budgets, and contract administration when required
Requirements
- B.Sc. or M.Sc. in life sciences or health related field
- A minimum of 18 years of experience in clinical research and development within a pharmaceutical, biotechnology, institutional, or CRO setting
- Demonstrated ability to lead and develop others within functional area
- Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, pharmacovigilance, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing
- Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations
- Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines
- Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets
- Excellent interpersonal, oral, and written communication skills
- Demonstrated strong negotiation and presentation skills
- Strong ability in problem-solving, including conflict resolution
Benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Life & AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- Pension plan
- Generous paid time off
- Sick leave
- Opportunity to earn a performance based bonus
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