Katalyst CRO
Overview
Join to apply for the
Sr. Clinical Data Manager
role at
Katalyst CRO .
Responsibilities
Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget.
Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated.
Manage interactions and deliverables with third-party vendors and CROs, ensuring proper execution of data management activities and providing relevant metrics to the study team.
Oversee data review, reconciliation, and cleaning activities for all assigned studies.
Ensure high data quality by adhering to corporate, industry, and regulatory standards.
Monitor outsourced data management activities for efficiency and regulatory compliance, providing feedback on vendor selection.
Cultivate effective working relationships with colleagues, junior staff, vendors, and management, solving problems and escalating issues with proposed solutions as needed.
Educate clinical team members on data management processes, workflow, and data standards.
Review and provide input on protocols, SOPs, and work instructions for the data management department.
Perform ongoing review of study documentation in the trial master file to ensure audit readiness.
Perform other related duties as required and assigned.
Qualifications
Bachelor's degree or equivalent combination of education, with 7+ years of relevant experience in clinical data management within biotech or pharmaceutical/drug development.
Preferred experience in vendor management and global operations.
Ability to work effectively in a smaller company environment, particularly in early development roles.
Strong planning and project management skills, including risk assessment and contingency planning.
Effective communication and interpersonal skills.
Ability to work as a team player in a complex, changing environment.
Self-motivated, independent, and results-oriented.
Excellent organizational and problem-solving skills with attention to detail.
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Join to apply for the
Sr. Clinical Data Manager
role at
Katalyst CRO .
Responsibilities
Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget.
Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated.
Manage interactions and deliverables with third-party vendors and CROs, ensuring proper execution of data management activities and providing relevant metrics to the study team.
Oversee data review, reconciliation, and cleaning activities for all assigned studies.
Ensure high data quality by adhering to corporate, industry, and regulatory standards.
Monitor outsourced data management activities for efficiency and regulatory compliance, providing feedback on vendor selection.
Cultivate effective working relationships with colleagues, junior staff, vendors, and management, solving problems and escalating issues with proposed solutions as needed.
Educate clinical team members on data management processes, workflow, and data standards.
Review and provide input on protocols, SOPs, and work instructions for the data management department.
Perform ongoing review of study documentation in the trial master file to ensure audit readiness.
Perform other related duties as required and assigned.
Qualifications
Bachelor's degree or equivalent combination of education, with 7+ years of relevant experience in clinical data management within biotech or pharmaceutical/drug development.
Preferred experience in vendor management and global operations.
Ability to work effectively in a smaller company environment, particularly in early development roles.
Strong planning and project management skills, including risk assessment and contingency planning.
Effective communication and interpersonal skills.
Ability to work as a team player in a complex, changing environment.
Self-motivated, independent, and results-oriented.
Excellent organizational and problem-solving skills with attention to detail.
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