Director, Project Management

🔥 19 hours ago

🇺🇸 United States – Remote

💵 $180k - $230k / year

⏰ Full Time

🔴 Lead

👷‍♀️ Project Manager

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• 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 the evolution of existing client portfolios, providing 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 are tracked and managed according to quality, operational, and financial budget standards • Support solution and budget development for complex and unique projects • Provide leadership, training, mentorship, and management oversight of project management staff • Review project management applicants and recommend hires in consultation with senior leadership • Develop and establish project management policies and Standard Operating Procedures • Support governing documents and work instructions for the department • Drive project management process and technology improvement initiatives • Develop reusable project management templates and training materials • Identify project issues and coordinate solutions with functional area directors and managers • Interact with clients on strategic partnership governance, pipeline and delivery planning, portfolio performance metrics, opportunities, innovation, and resource projections • Manage project management aspects of assigned Phase I–IV clinical trials in accordance with 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, timelines, hours, budgets, financial status, and expenses; escalate major deviation risks • Facilitate problem solving and conflict resolution and act as a second-level escalation resource • Conduct lessons learned meetings • Contribute to staff performance evaluations • Assist with RFIs/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 • Line management experience required • 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) • 401(k) retirement • Generous paid time off • Sick leave • Opportunity to earn a performance based bonus • Remote work opportunity