Lead Clinical Data Manager
At Cytel, we prioritize the professional development of our staff while advancing innovative treatment options for patients. We create a successful career journey for our employees, ensuring that they significantly contribute to our mission. Cytel is where talent, experience, and integrity unite to enhance clinical development.
Your Role:
We are on the lookout for a seasoned and strategic Lead Clinical Data Manager to drive the evolution of our data management practices. This crucial role involves redefining core clinical data management workflows, creating comprehensive SOPs, and ensuring smooth execution across all clinical trial phases. You are a dynamic, inspiring leader who motivates teams and fosters collaboration, always striving for the next level in clinical development.
What You Will Do:
- Process Innovation & Leadership:
- Redesign end-to-end data management processes for internal execution, covering study start-up, maintenance, and close-out.
- Assess and refine existing procedures to enhance efficiency, compliance, and scalability.
- SOP & Process Flow Creation:
- Create and implement SOPs and interactive process maps that comprehensively outline the data management lifecycle.
- Ensure documentation is aligned with best practices and aids cross-functional understanding and training.
- Function Ownership:
- Oversee the transformation of key 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
- Collaboration Across Teams:
- Partner with leaders and cross-functional teams to define deliverables and ensure alignment with broader program goals.
- Provide subject matter expertise and strategic guidance to facilitate project planning and execution.
- Quality Assurance & Compliance:
- Ensure all processes and deliverables adhere to regulatory standards and internal quality benchmarks.
- Support initiatives for audit readiness and continuous improvement.
- Post-Project Transition:
- Move into a hands-on Clinical Data Manager role, which includes:
- Representing data management in clinical trial working groups, ensuring aligned expectations for data-related deliverables, especially for key decisions and regulatory submissions.
- Collaborating across functions to guarantee data quality and timely delivery of data management deliverables.
- Showing influential leadership with client stakeholders to meet established milestones and maintain superior quality.
- Coordinating with other functions (Clinical Operations, Statistical Programming, and Statistics) to ensure achievement of major data management deliverables.
- Contributing to continuous improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines and budget.
- Ensuring accountability for personal Learning Curricula and compliance with corporate and GXP standards.
Here at Cytel, we want you to succeed, and we empower that success through robust training, development, and support. To thrive in this role, you should possess:
- Bachelor's degree in Life Sciences, Health Informatics, or a related field
- 10+ years of progressive experience in clinical data management, with notable experience in a leadership or principal role.
- Proven ability in process development, SOP writing, and cross-functional collaboration.
- Strong understanding of EDC systems, CDISC standards, and regulatory requirements.
- Exceptional communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered. Cytel Inc. is a Global CRO offering innovative biostatistical software and services to large pharma and emerging biotech clients. Our commitment is to keep patients at the center of our efforts as we accelerate the development of drugs and devices that save lives and enhance quality of life.
At Cytel, we provide a comprehensive and competitive total rewards package along with world-class employee benefits, supportive policies, and well-being initiatives tailored for your and your family’s success throughout your career.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions irrespective of race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristic protected by law.