Director, Clinical Data Management

Join The CTI Team•Covington, KY

About The Position

This role is responsible for supporting the development of Global Standard Operating Procedures (GSOPs), preparing and defending study-specific fee estimates, presenting Clinical Data Management (CDM) capabilities to clients, and communicating project progress, staffing, and resource allocation to the Senior Director. The position involves developing and executing a resource plan that supports the business, identifying technology needs or other gaps, and identifying and communicating risks to the business while developing solution-oriented approaches. The Director will troubleshoot and resolve critical issues impacting the optimal functioning of the team. They will provide direction for CDM team members regarding project deliverables, ensuring they are on schedule, meet quality standards, and adhere to project budget from study start-up through archival. This role also includes direct supervision, guidance, and mentoring of CDM staff, encouraging independence and refining their skills. Providing effective and timely feedback for performance reviews of project team members is crucial. Maintaining open communication with internal and external customers, including sponsor counterparts, responding promptly to correspondence, and choosing appropriate communication methods based on urgency and information type are key. The Director will evaluate team requests by considering efficiency, quality, budget, resources, and customer relations before committing to actions, and will seek existing knowledge before developing new methods.

Requirements

Excellent verbal and written communication skills
Knowledge of Data Management systems including Medidata Rave, OmniComm TrialMaster, and IBM Clinical Development
Knowledge of regional regulations relative to clinical trial conduct, as well as ICH E6 Good Clinical Practice
Base background / knowledge regarding medical terminology and drug nomenclature
Ability to work independently and be self-motivated
Base background / knowledge of the drug development and clinical research process
Demonstrated ability to lead project teams
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
Experience with EDC systems including Medidata Rave and OmniComm TrialMaster
At least 8 years direct line management experience

Responsibilities

Support the 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 Senior Director
Prepare and execute a resource plan that supports the business
Identify technology needs or other gaps
Identify and communicate risks to the business and develop solution-oriented approaches to address or mitigate risk
Trouble-shoot responsibility by resolving critical issues that impact optimal functioning of the team
Provide direction of activities of Clinical Data Management (CDM) team members regarding completion of project deliverables to ensure they are on schedule according to quality standards, requirements, and project budget from study start-up through archival
Provide direct supervision, guidance, and mentoring to CDM staff while encouraging independence and refining skills of staff
Provide effective and timely feedback to management for performance reviews of project team members on an ongoing basis
Maintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes, and choosing method of communication based on urgency and type of information including governance calls with Sponsors
Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action
Seek out existing knowledge prior to developing new methods