Director, Clinical Data Management

CTI; Covington (KY); Hybrid; USD 90,000 - 150,000; Full time

Benefits offered by this job

Health benefits

Hybrid work from home opportunities

Paid parental leave

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services is seeking a senior Clinical Data Management (CDM) leader in the Covington, KY area to oversee study deliverables, timelines, and staffing. You will guide the CDM team from study start-up through archival, ensuring high quality, budget compliance, and client satisfaction.

The role requires a BA/BS in Life Sciences with 12+ years in CDM or a Master’s with 10+ years, hands-on experience with Medidata Rave and TrialMaster, and at least 8 years of direct

Qualifications

• BA/BS in Life Sciences with 12+ years in CDM, or Master’s with 10+ years.
• Experience with EDC systems including Medidata Rave and OmniComm TrialMaster.
• At least 8 years direct line management experience.

Responsibilities

• Support development of GSOPs and defend study-specific fee estimates to clients.
• Present CDM capabilities and communicate project progress to Senior Director, Data Management.
• Plan and execute a resource plan, identify risks, and develop mitigation strategies.
• Provide direction and mentoring to CDM staff through study start-up to archival.
• Provide ongoing feedback for performance reviews and maintain sponsor communications.

Skills

Project leadership

Resource planning

Communication skills

Independent work

Education

BA/BS in Life Sciences

Master’s degree in Life Sciences

Tools

Medidata Rave

OmniComm TrialMaster

Job description

Essential Functions:

• Support the development of CDM Global Standard Operating Procedures (GSOPs)
• Prepare and defend study specific fee estimates to clients, present CDM capabilities to clients, and communicate project progress, staffing and resource allocation to Senior Director, Data Management
• Plan 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

Competencies:

• 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

Required Education/Experience:

• 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

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

• We will never communicate directly with you via Microsoft Teams Messaging or by text message
• We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review Know Your Rights notice from the Department of Labor.