Sr. Clinical Data Manager
Sr. Clinical Data Manager
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Salary Not Disclosed
1 Vacancy
Job Description
- 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.
- Bachelors degree or equivalent combination of education 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.
Employment Type
Full Time
