Senior Project Manager

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 11%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Lead the execution of clinical research projects or programs and ensure compliance with applicable regulations, guidelines, and corporate policies • Lead projects through the full cycle, including scope, budget, and resource assessment • Act as primary liaison between the company and sponsors for project launch, conduct, and closeout • Communicate with sponsors, cross-functional teams, project vendors, and site staff • Communicate project progress, generate periodic updates, and prepare formal presentations • Coordinate with clinical, marketing, and operations management to identify study goals and scope • Ensure operational and regulatory integrity of assigned studies • Participate in FDA or other regulatory authority inspections as needed • Develop study plans, informed consent forms, case report form instructions, site selection materials, investigator updates, and other project documents • Identify project risks and analyze scope, cost, resource, and timeline impacts • Develop, manage, and track project budgets • Implement project management tools, techniques, and processes for informed decision-making • Participate in clinical data review and analysis • Train, mentor, and coach junior staff and provide feedback • Ensure tasks meet client expectations and comply with contracts, trial protocols, and SOPs • Support continuous improvement of project delivery practices • Maintain current knowledge of FDA regulations and GCP and ICH Guidelines • Supervise assigned team members and provide higher-level guidance on project management tools and processes • Attend off-site meetings and conferences as needed

🎯 Requirements

• Bachelor degree or equivalent education/degree in life science/healthcare is required • 8 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program • CRO experience is highly desirable • Experience qualifying and managing external vendors • Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies • Experience writing, reviewing, and editing protocols and clinical study reports • Working knowledge of the FDA submission process • Knowledge of FDA regulations and GCP and ICH Guidelines for clinical research • Extensive organizing and coordinating skills • Teaching and facilitation skills • Ability to assess training needs and objectives • Extensive experience overseeing and coordinating the work of others • Ability to handle multiple tasks simultaneously and manage multiple deadlines • Ability to exercise judgment and determine appropriate action for problems of varying complexity • Strong desire to take ownership of multiple projects

🏖️ Benefits

• Attend off-site meetings and conferences, as needed • Educational opportunities and professional development through reading professional publications, maintaining professional networks, and participating in professional organizations

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