
Director, Project Management
Posted 4 days ago

Posted 4 days ago
This is a fully remote position, open to applicants in United States.
• Supervise the planning, communication, and execution of clinical research and development services.
• Strategize and execute new client service delivery requests within the existing client portfolio.
• Assist in the growth of current client portfolios by offering comprehensive biometrics and full-service project deliveries across clinical development programs.
• Coordinate efforts among functional area directors and managers in project planning, task identification, deliverable definition, and resource assessment.
• Monitor project and portfolio performance utilizing strategic planning and project tracking methodologies and tools.
• Conduct reviews of project progress and facilitate governance meetings with Everest and clients.
• Ensure that projects are tracked and managed in compliance with quality, operational, and financial budget standards.
• Aid in developing solutions and budgets for complex and unique projects.
• Provide leadership, training, mentorship, and managerial oversight to project management personnel.
• Evaluate project management applicants and recommend selections in collaboration with senior leadership.
• Formulate and implement project management policies and Standard Operating Procedures.
• Support the creation of governing documents and work instructions for the department.
• Propel initiatives for improving project management processes and technology.
• Create reusable project management templates and training resources.
• Identify project-related challenges and coordinate resolutions with functional area directors and managers.
• Engage with clients on strategic partnership governance, pipeline and delivery planning, portfolio performance metrics, opportunities, innovation, and resource forecasts.
• Oversee project management components of assigned Phase I–IV clinical trials in compliance with applicable guidelines and regulations.
• Lead cross-functional project teams effectively.
• Manage all aspects of project planning, implementation, execution, and reporting within established timelines, budgets, quality standards, and regulatory guidelines.
• Track project tasks, timelines, hours, budgets, financial status, and expenses, and escalate any significant deviation risks.
• Facilitate problem-solving and conflict resolution, serving as a secondary escalation resource.
• Conduct meetings to review lessons learned.
• Contribute to the performance evaluations of staff.
• Assist with RFIs/RFPs, bid defense meetings, work scopes, budgets, and contract administration as needed.
• Bachelor’s or Master’s degree in life sciences or a related health field.
• A minimum of 18 years of experience in clinical research and development in a pharmaceutical, biotechnology, institutional, or CRO environment.
• Required line management experience.
• Proven ability to lead and develop individuals within a functional area.
• Comprehensive 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 of ICH guidelines, FDA, Health Canada, and EMA regulations is essential.
• Capability to define scopes, estimate budgets, and manage projects effectively, including resource requirements, utilization, hours versus budgets, key deliverables, and timelines.
• Demonstrated leadership skills, including setting objectives for others and driving achievement in alignment with allocated resources, timelines, and budgets.
• Exceptional interpersonal, oral, and written communication abilities.
• Strong negotiation and presentation skills are essential.
• Excellent problem-solving skills, including conflict resolution capabilities.
• Medical coverage.
• Dental coverage.
• Vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• 401(k) retirement plan.
• Generous paid time off.
• Sick leave.
• Opportunity to earn a performance-based bonus.
• Remote work opportunity.
[Bulle & Mensch] – So handeln Profis wirklich.
Nor-Cal Controls ES, Inc.
Mercor
SCALIA - Global People Operations Agency
Get handpicked remote jobs straight to your inbox weekly.