Sr. Clinical Data Manager

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 85,000 - 125,000; Full time

Job summary

CTI Clinical Trial and Consulting Services in Covington, KY seeks a senior CDM leader to drive data management from study start-up to archival. You will oversee deliverables, ensure data quality, and manage budgets, collaborating with sponsors and cross-functional teams.

The role requires a life sciences or nursing degree, 5+ years CDM experience, and knowledge of Medidata Rave or TrialMaster. CTI offers a dynamic, collaborative environment with growth opportunities.

Qualifications

• Bachelor’s degree in life sciences or nursing or related field.
• Minimum 5 years of Clinical Data Management experience in pharma/CRO.
• Strong knowledge of regulatory guidelines and GSOPs.
• Experience with Medidata Rave or similar CDM systems.

Responsibilities

• Direct activity of CDM team to ensure on-schedule deliverables and budget alignment.
• Represent CTI CDM on project teams and coordinate with sponsors.
• Maintain CDM study files and define data cleaning guidelines and workflows.
• Monitor timelines and communicate impact on milestones to management.
• Ensure data quality and compliance with GSOPs across projects.
• Manage CDM project budget and highlight any out-of-scope work.
• Provide training and mentorship to junior CDM staff.
• Prepare and present project reports to sponsors and CTI management.

Skills

Senior CDM Leadership

Regulatory guidelines

Data management

Communication skills

GSOP knowledge

Education

Bachelor’s degree in life sciences or nursing

5+ years CDM experience

2+ years relational database experience

Medidata Rave/OmniComm/TrialMaster experience

Job description

• Direct activity of CDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from study start-up through archival
• Serve as CTI CDM representative on project teams
• Recommend alternative work processes to improve quality or speed of customer deliverables and respond to questions on CDM process, timelines, and data quality
• Maintain positive working relationship with internal customers and sponsor by keeping them up-to-date about progress of projects and working with them to develop coordinated plans that meet customers’ needs
• 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 being communicated
• 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
• Develop and maintain CDM study files; Identify all internal and sponsor CDM deliverables contracted in scope of work and establish time estimates; Specify data cleaning guidelines, conventions, Global Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements
• Continuously evaluate timelines in relation to work completed and communicate impact on milestones to CDM management, project team members, and sponsor
• Maintain consistent, manageable workflow for CDM project team by monitoring enrollment information and communicating with project team to actively influence data collection
• Monitor quality of work performed by CDM project team and compliance with GSOPs and provide feedback to team
• Maintain CDM project budget by identifying CDM activities outside scope of contracted work, obtaining agreement from sponsor or CTI management prior to performing out-of-scope tasks, preparing or reviewing budget and cost analysis documentation routinely, and following scope issues through to resolution
• Provide or arrange for adequate project specific training for CDM team members
• Serve as a mentor to lower level Clinical Data Managers for all tasks
• Develop project reports which meet needs of sponsors, project team, and CTI management, are accurate, and are provided to sponsor and CDM management upon request or a re-arranged schedule
• Coordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], serious adverse events, etc.) and direct reconciliation where applicable
• Prepare in advance for internal and external meetings, complete action items within required timeframe, and attend internal meetings regularly, providing input, and demonstrating respect for opinions of others
• Maintain current study documentation and CDM project plan which accurately reflect process deviations and changes in project assumptions or scope of contracted work
• Conduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to CDM management

Essential Functions

• Direct activity of CDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from study start-up through archival
• Serve as CTI CDM representative on project teams
• Recommend alternative work processes to improve quality or speed of customer deliverables and respond to questions on CDM process, timelines, and data quality
• Maintain positive working relationship with internal customers and sponsor by keeping them up-to-date about progress of projects and working with them to develop coordinated plans that meet customers’ needs
• 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 being communicated
• 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
• Develop and maintain CDM study files; Identify all internal and sponsor CDM deliverables contracted in scope of work and establish time estimates; Specify data cleaning guidelines, conventions, Global Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements
• Continuously evaluate timelines in relation to work completed and communicate impact on milestones to CDM management, project team members, and sponsor
• Maintain consistent, manageable workflow for CDM project team by monitoring enrollment information and communicating with project team to actively influence data collection
• Monitor quality of work performed by CDM project team and compliance with GSOPs and provide feedback to team
• Maintain CDM project budget by identifying CDM activities outside scope of contracted work, obtaining agreement from sponsor or CTI management prior to performing out-of-scope tasks, preparing or reviewing budget and cost analysis documentation routinely, and following scope issues through to resolution
• Provide or arrange for adequate project specific training for CDM team members
• Serve as a mentor to lower level Clinical Data Managers for all tasks
• Develop project reports which meet needs of sponsors, project team, and CTI management, are accurate, and are provided to sponsor and CDM management upon request or a re-arranged schedule
• Coordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], serious adverse events, etc.) and direct reconciliation where applicable
• Prepare in advance for internal and external meetings, complete action items within required timeframe, and attend internal meetings regularly, providing input, and demonstrating respect for opinions of others
• Maintain current study documentation and CDM project plan which accurately reflect process deviations and changes in project assumptions or scope of contracted work
• Conduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to CDM management

Competencies

• Excellent verbal and written communication skills
• Knowledge of regulatory guidelines
• Knowledge regarding medical terminology and drug nomenclature
• Knowledge of the drug development and clinical research process
• Excellent written and oral communication skill

Required Education/Experience

• Bachelor’s degree in nursing or life science and/or equivalent combination of education and clinical research experience
• Minimum 5 years of related Clinical Data Manager experience in either pharmaceutical or CRO environment
• 2 years of relational database experience
• Experience with Medidata Rave or OmniComm, TrialMaster

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 invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
• Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note

In light of 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 our website (www.ctifacts.com) or from our 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

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