Associate Director – Project Management

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🔥 0 minutes ago

🇨🇦 Canada – Remote

💵 $170k - $220k / year

⏰ Full Time

🟠 Senior

👷‍♀️ 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 • Train, manage, and oversee Project Managers, including performance assessments • Review new Project Manager applicants and recommend hires for interview processing in consultation with the President • Develop, update, and review governing documents for the functional area • Plan and implement new client service delivery requests and support evolution of the existing client portfolio • Further develop and establish project management policies and SOPs and assure quality deliverables • Facilitate project planning, task and deliverable identification, resource assessment, and utilization • Track project progress using strategic planning and project tracking methods and tools • Provide monthly project progress status reports • Conduct project progress status meetings and identify issues requiring follow-up or immediate action • Ensure smooth project start-up, continuation, and successful completion with functional area directors and managers • Interact with clients regarding resource requirements and project management purposes • Manage projects involving data management, statistics, medical writing, subject randomization and drug supply management (IWRS), data monitoring and adjudication committees, and regulatory submissions • Define work scopes and estimate budgets; develop and manage cross-functional project work plans, resources, budgets, quality deliverables, and timelines • Manage Phase I–IV clinical trials according to ICH guidelines, FDA, Health Canada, EMA, and other applicable requirements • Lead cross-functional project teams • Manage project planning, implementation, conduct, and reporting within timelines, budgets, quality standards, and regulatory requirements • Coordinate activities between Everest, trial sponsors, supporting groups, and vendors • Track financial status against budgets and reconcile expenses across activity sub-streams • Track tasks against timelines and hours spent/budgets and alert management to major deviation risks • Prepare project status reports and present project status to internal and external stakeholders • Facilitate meetings, problem solving, and conflict resolution • Communicate action items and key decisions through minutes and follow-up actions • Conduct lessons-learned meetings • Contribute to or participate in staff performance evaluations • Assist with Requests for Information and Requests for Proposals, work scopes, budgets, and contract administration when required • Perform clinical trial planning, management, and site monitoring from trial initiation to closure when required

🎯 Requirements

• B.Sc. or M.Sc. in life sciences or health related field • 12+ years’ experience in clinical research and development within a pharmaceutical, biotechnology 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, 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 • Experienced as a clinical trial monitor, initiating, monitoring and closing out clinical trials will be desirable

🏖️ Benefits

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • a pension plan • generous paid time off and sick leave • opportunity to earn a performance based bonus • Remote work from a home-based office anywhere in Canada in accordance with Work from Home policy