Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you’ll be at the heart of our client’s innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
ShortDescriptionStr

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• Bachelor’s degree in Life Sciences, Health Informatics, or related field
• 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
• Proven expertise in process development, SOP writing, and cross-functional collaboration.

• Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.Excellent communication, organizational, and problem-solving skills.

• An equivalent combination of education and experience may be considered in lieu of stated requirements.
  InternalQualificationsStr

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• Bachelor’s degree in Life Sciences, Health Informatics, or related field
• 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
• Proven expertise in process development, SOP writing, and cross-functional collaboration.

• Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.Excellent communication, organizational, and problem-solving skills.

• An equivalent combination of education and experience may be considered in lieu of stated requirements.
  InternalResponsibilitiesStr

AS A PRINCIPAL CLINICAL DATA MANAGER, YOUR RESPONSIBILITIES WILL INCLUDE:

• Process Reengineering & Oversight:
• Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
• Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
• SOP & Process Flow Development:
• Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
• Ensure documentation reflects best practices and supports cross-functional understanding and training.
• Functional Area Ownership:
• Oversee the reengineering of critical data management functions, including:
• Study Set-Up
• EDC Build and Maintenance
• Data Cleaning and Query Management
• Local Lab and External Data Handling
• Clinical Coding
• SAE Reconciliation
• Blinding Procedures
• Site Close-Out and Database Lock
• DM Metrics and Clean Patient Tracker
• Cross-Functional Collaboration:
• Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
• Provide subject matter expertise and strategic input to support project planning and execution.
• Quality & Compliance:
• Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
• Support audit readiness and continuous improvement initiatives.
• Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:
• Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
• Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
• Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
  ExternalResponsibilitiesStr

AS A PRINCIPAL CLINICAL DATA MANAGER, YOUR RESPONSIBILITIES WILL INCLUDE:

• Process Reengineering & Oversight:
• Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
• Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
• SOP & Process Flow Development:
• Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
• Ensure documentation reflects best practices and supports cross-functional understanding and training.
• Functional Area Ownership:
• Oversee the reengineering of critical data management functions, including:
• Study Set-Up
• EDC Build and Maintenance
• Data Cleaning and Query Management
• Local Lab and External Data Handling
• Clinical Coding
• SAE Reconciliation
• Blinding Procedures
• Site Close-Out and Database Lock
• DM Metrics and Clean Patient Tracker
• Cross-Functional Collaboration:
• Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
• Provide subject matter expertise and strategic input to support project planning and execution.
• Quality & Compliance:
• Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
• Support audit readiness and continuous improvement initiatives.
• Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:
• Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
• Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
• Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.