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Clinical Research Project Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

đźź  Senior

đź§Ş Clinical Research

đź‘» Ghost score 12%

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Evolution Research Group

501 - 1000 employees

Founded 2014

đź’Ľ 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.

đź“‹ Description

• Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies • Manage and execute overall project scope, budget, and timelines • Identify project success factors for analysis, reporting, and tracking • Manage resources and timelines for study start-up and implementation activities • Lead development of study-specific protocols, consent forms, and other trial-related materials • Ensure development of study documents, including study plans, case report form instructions, site selection materials, investigator updates, and project-specific documents • Participate in clinical data review for analysis • Ensure project tasks meet client expectations and comply with contracts, trial protocols, and SOPs • Serve as liaison between clients and internal teams, proactively communicating project information and updates • Plan and manage materials supporting clinical project execution, including documents, forms, supplies, equipment, and investigational devices • Monitor adherence to project contracts and budgets • Coordinate with clinical, business development, and operations management to identify study project goals and scope • Ensure operational and regulatory integrity of assigned studies • Participate in FDA or other regulatory authority inspections as needed • Support management and oversight of clinical study vendors • Review site monitoring reports and ensure finalization according to SOPs and contractual requirements • Participate in departmental or corporate initiatives • Maintain job knowledge through educational opportunities, professional publications, networks, and professional organizations • Attend off-site meetings and conferences as needed

🎯 Requirements

• Bachelor’s degree or equivalent education/degree in life science/healthcare required • 5 years of experience working within clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program • CRO experience highly desirable • Experience managing external vendors preferred • Experience leading project operational teams through study start-up, study conduct, data management, and report writing preferred • Experience writing, reviewing, and editing protocols and clinical study reports preferred • Working knowledge of the FDA submission process preferred • Ability to facilitate a teamwork philosophy with a positive attitude • Organizing and coordinating skills • Teaching and facilitation skills • Ability to assess training needs and objectives for the team • Experience overseeing and coordinating the work of others • Ability to handle multiple tasks simultaneously effectively and efficiently • Ability to exercise judgment and determine appropriate action for problems of varying complexity • Ability to manage multiple deadlines • Strong computer skills, including Microsoft Office • Ability to meet physical requirements, including periodically lifting and/or carrying up to 10 pounds • Safety awareness in home and travel environments

🏖️ Benefits

• 100% remote work • Educational opportunities • Attendance at off-site meetings and conferences, as needed

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