CRO Project Manager – Contract

🔥 15 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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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

• 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, including CRO/investigator agreements and contractual agreements • Lead development of study-specific protocols, consent forms, and 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 review of clinical data for analysis • Ensure project tasks meet client expectations and comply with contracts, trial protocols, and SOPs • Serve as liaison between clients, internal teams, and study sites; proactively communicate project information and updates • Manage materials supporting clinical project execution, including documents, forms, supplies, equipment, and investigational devices • Monitor adherence to project contracts and budgets • Coordinate with clinical, marketing, and operations management to identify clinical study 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 for SOP and contractual compliance • Provide therapeutic training and guidance to the clinical team • Participate in departmental or corporate initiatives • Perform other related duties as required

🎯 Requirements

• Bachelor’s degree or equivalent education/degree in life science/healthcare is required • 5 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 study 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 • 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 • Ability to exercise judgment and determine appropriate action for problems of varying complexity • Ability to manage multiple deadlines • Strong computer skills, including Microsoft Office

🏖️ Benefits

• Attending off-site meetings and conferences, as needed • Educational opportunities, professional publications, personal networks, and professional organizations for maintaining job knowledge