Director, Clinical Data Management

🔥 17 hours ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ 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

• Support development of CDM Global Standard Operating Procedures (GSOPs) • Prepare and defend study-specific fee estimates to clients • Present CDM capabilities to clients • Communicate project progress, staffing, and resource allocation to the Senior Director • Plan and execute resource plans supporting the business • Identify technology needs and other gaps • Identify and communicate business risks and develop solution-oriented approaches to address or mitigate them • Resolve critical issues impacting optimal team functioning • Direct CDM team activities and ensure project deliverables are on schedule, meet quality standards and requirements, and remain within budget from study start-up through archival • Supervise, guide, and mentor CDM staff while encouraging independence and refining staff skills • Provide timely feedback to management for project team members’ performance reviews • Maintain communication with internal and external customers and sponsor counterparts • Participate in governance calls with sponsors • Evaluate team requests based on efficiency, quality, budget, resources, and customer relations before taking action • Seek existing knowledge before developing new methods

🎯 Requirements

• BA/BS in Life Sciences with at least 12 years of experience in CDM, or Master’s degree with at least 10 years of experience • At least 8 years of direct line management experience • Experience with EDC systems including Medidata Rave and OmniComm TrialMaster • Knowledge of data management systems including Medidata Rave, OmniComm TrialMaster, and IBM Clinical Development • Knowledge of regional regulations relative to clinical trial conduct and ICH E6 Good Clinical Practice • Background/knowledge regarding medical terminology and drug nomenclature • Background/knowledge of the drug development and clinical research process • Demonstrated ability to lead project teams • Excellent verbal and written communication skills • Ability to work independently and be self-motivated

🏖️ Benefits

• Reasonable accommodation for applicants with disabilities • Full-time employment