Clinical Data Manager I

What You'll Do:

• Perform and/or 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
• Develop and maintain study specific documents including: Case Report Forms, CRF Completion Guidelines, Clinical Data Management Plan, Annotated CRFs, and Edit Specifications
• Serve as CTI CDM representative on project teams
• 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 and effective 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 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
• 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 per a predefined schedule
• Coordinate receipt and handling of data received from external sources (i.e., central laboratory, electrocardiogram [ECG], sponsor-coding dictionaries) 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 specific documentation to 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

• Medical Coding

• Database development and programming including functional testing
• Clinical data review
• Provide or arrange for adequate project specific training for CDM team and other study team members
• 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 Potential Additional Functions:
• Recommend alternative work processes to improve quality or speed of customer deliverables and respond to questions on CDM process, timelines, and data quality

What You'll Bring:

• 2 years of related Clinical Data Management experience in either pharmaceutical or CRO environment
• Bachelor's degree in nursing or life science and/or equivalent combination of education and clinical research experience
• Experience with IBM Clinical Development, Medidata Rave or OmniComm TrialMaster

2 years of relational database experience

About CTI
Advance Your Career - We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.

Join 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 hybrid work opportunities. 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 email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ) or from our verified LinkedIn page.

Please Note

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any point during the recruitment process