Clinical Research Project Manager

🕒 May 5

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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 ensures compliance with applicable regulations, guidelines, and corporate policies for study activities. • Manage and execute the overall project scope, budget, and timelines. • Identify project success factors for analysis, reporting, and tracking. • Manage resources and timelines associated with all study start-up and implementation activities. • Lead the development of study specific protocols, consent forms, and other trial related materials as required. • Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies. • Participate in the review of clinical data for analysis. • Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs). • Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated. • Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices. • Monitor adherence to project contract and budget. • Coordinate with clinical, business development, and operations management to identify goals and scope of clinical study projects. • Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. • Support the management and oversight of clinical study related vendors. • Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements. • Enhance department and organization reputation by participating in departmental or corporate initiatives. • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. • Attend off-site meetings and conferences, as needed.

🎯 Requirements

• Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program. • CRO experience is highly desirable. • Experience managing external vendors preferred. • Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies preferred. • Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process preferred.

🏖️ Benefits

• 100% Remote