Director, Clinical Data Management

About the Role

Director, Clinical Data Management

Location: United States - Remote
Work Arrangement: 100%
Employment Type: Full-Time
People Management: Yes 

Job Description

Essential Functions

• Support the development of Clinical Data Management Global Standard Operating Procedures (GSOPs).

• Prepare and defend study-specific fee estimates to clients, present Clinical Data Management capabilities to clients, and communicate project progress, staffing, and resource allocation to the 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; troubleshoot 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 counterparts on an agreed-upon schedule, responding to correspondence promptly and within agreed-upon timeframes, and choosing the 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 and knowledge regarding medical terminology and drug nomenclature.

• Ability to work independently and be self-motivated.

• Base background and knowledge of the drug development and clinical research process.

• Demonstrated ability to lead project teams.

Required Education and Experience

• Bachelor of Arts or Bachelor of Science in Life Sciences with at least 12 years of experience in Clinical Data Management, or a Master’s degree with at least 10 years of experience.

• Experience with Electronic Data Capture (EDC) systems, including Medidata Rave and OmniComm TrialMaster.

• At least 8 years of direct line management experience.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical

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 work-life balance and the importance of time with family by offering generous health benefits and vacation packages,

• 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.

Important Note

In light of the recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on the CTI website or from its verified LinkedIn page.

Please Note

• 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 the "Know Your Rights" notice from the Department of Labor.