Associate Director, Clinical Project Management

🔥 0 minutes ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Lead management of multiple Phase I-IV clinical research trials across geographic and functional areas • Plan, implement, facilitate and evaluate assigned clinical trials from planning through analysis and client delivery • Oversee clinical trial operations, activities, deliverables, timelines, budgets and quality • Ensure compliance with ICH guidelines, GCP, regulatory guidelines and trial procedures • Coordinate Clinical Project Managers, Clinical Project Coordinators, functional teams and clients • Serve as senior interface with CTI executive management and sponsors • Identify, escalate and resolve trial, staffing and organizational issues • Prepare and oversee study plans, project timelines, status reports, meeting agendas and minutes • Assess resource needs and establish project teams • Track project progress, metrics, budgeted hours and scope against contractual agreements • Support scope changes, contract amendments, new business proposals, budgeting, presentations and business development • Train, supervise, guide and mentor CPMs and CPC staff • Review quality assurance reports and ensure corrective actions • Lead process improvement initiatives and develop reference and resource materials • Keep CTI executive management and clients informed of project progress and issues

🎯 Requirements

• Bachelor’s degree in an allied health field such as nursing, pharmacy or health science, preferably with clinical trial management experience, or an equivalent combination of education and relevant work experience • At least 10 years of clinical research experience and/or clinical project management experience • Clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas • Experience managing clinical trials • Thorough and current understanding of at least one therapeutic area for which CTI is contracted for clinical projects preferred • Knowledge of ICH guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures

🏖️ Benefits

• Up to $25K sign-on bonus • Structured mentoring program • Leadership development courses • Ongoing education and training opportunities • Tuition reimbursement • Generous health benefits • Vacation packages • Hybrid work opportunities • Paid parental leave • CTI Cares community and global volunteering opportunities • Professional growth and career development support