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Role Description
The Senior Project Manager position is responsible for taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation.
• Perform overall company-wide project progress tracking utilizing strategic planning and project tracking methods and tools.
• Ensure that ongoing projects have existing project plans as required by the established Standard Operating Procedures (SOPs).
• Work with functional area directors and managers to ensure smooth project start-up, continuation, and successful completion.
• Interact with clients for projection of resource requirements and project management purposes.
• Define project scope and estimate budgets, planning, directing, leading project activities, managing resources and budgets.
• Accountable for reporting project progress status to internal management and clients.
• Assist in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP).
Qualifications
• Bachelor of Science or Master of Science in life sciences or health related field.
• Over 10 years of experience in clinical research and development within a pharmaceutical, biotechnology or Clinical Research Organization (CRO) setting.
• Minimum of 7 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks.
• Pain Management experience is required.
• Knowledge of clinical research process inclusive of Phase I trials through regulatory submission.
• Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Demonstrated understanding of cross-functional processes including site selection, study start-up, clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.
• Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
• Solid financial acumen including the ability to define scope and estimate budgets, and plan and manage projects.
• Excellent interpersonal and oral and written communication skills.
• Strong ability in problem-solving including conflict resolution.
Requirements
• Proficiency in project management tools and methodologies.
• Ability to manage multiple projects simultaneously.
• Strong negotiation and presentation skills.
• Ability to identify out-of-scope work and initiate change order discussions.
• Willingness to travel, up to 20%, including international travel.
Benefits
• Flexible work-from-home policy.
• Opportunities for professional development and growth.
• Supportive and dynamic work environment.
Company Description
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
• Founded in 2004 as an independent CRO.
• Headquartered in Markham, Ontario, Canada.
• Additional locations in Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe.
• Known for high quality deliverables, superior customer service, and flexibility.
• Dynamic organization with an entrepreneurial origin.
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