Director, Clinical Data Management

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Assist in the development of CDM Global Standard Operating Procedures (GSOPs)

• Prepare and justify study-specific fee estimates for clients

• Showcase CDM capabilities to prospective clients

• Update the Senior Director on project progress, staffing, and resource distribution

• Strategize and implement resource plans that support the business objectives

• Identify technology requirements and other deficiencies

• Recognize and communicate business risks while formulating solution-oriented strategies to address or reduce them

• Resolve crucial issues that affect optimal team performance

• Oversee CDM team operations, ensuring that project deliverables are timely, meet quality standards, and stay within budget from study initiation to archival

• Mentor, guide, and supervise CDM personnel while promoting autonomy and enhancing their skills

• Provide prompt feedback to management regarding the performance evaluations of project team members

• Maintain consistent communication with both internal and external clients and sponsor representatives

• Engage in governance discussions with sponsors

• Assess team requests based on efficiency, quality, budget, resources, and client relations prior to taking action

• Utilize existing knowledge before creating new methodologies

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences, with a minimum of 12 years or 10 years of experience in CDM, respectively

• At least 8 years of experience in direct line management

• Familiarity with EDC systems, including Medidata Rave and OmniComm TrialMaster

• Understanding of data management systems such as Medidata Rave, OmniComm TrialMaster, and IBM Clinical Development

• Awareness of regional regulations pertaining to clinical trial execution and ICH E6 Good Clinical Practice

• Knowledge of medical terminology and drug nomenclature

• Understanding of the drug development and clinical research processes

• Proven ability to lead project teams effectively

• Exceptional verbal and written communication capabilities

• Capacity to work autonomously and possess self-motivation

🏝️ Benefits

• Reasonable accommodations for applicants with disabilities

• Full-time employment