Senior Clinical Data Manager
2 tygodni temu
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Senior Clinical Data Manager (all genders), WarsawLocation:Warsaw, Poland
Job Category:Other
EU work permit required:Yes
Job Reference:b1a9c4900493
Job Description:This role can be done in fully remote model. A great opportunity has opened within the Data Monitoring, Management and Innovation department to further strengthen our Clinical Data Management team. You will play a crucial role in managing and overseeing clinical data management activities within the organization.
You will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data, while also coordinating a team of clinical data management professionals in a matrix setting. To be successful in this role you would demonstrate accountability for all Clinical Data Management related deliverables in assigned global (Phase I-IIIb) trials of varying complexity.
- Define and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding).
- Ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive data review and validation activities.
- Represent Clinical Data Management within the Core Trial Team and serve as key point of contact for the Data Management related tasks in a trial/project/program.
- Ensure quality of clinical database/deliverables (incl. eCRF and external data) as well as submission readiness of the clinical data management deliverables and data packages (e.g. CDISC).
- Provide project management for all clinical data management related deliverables e.g. planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc.
- Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s).
- Contribute to the development and maintenance of data management SOPs, work instructions, and best practices.
Minimum of 8 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry. Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement. Demonstrated ability to lead and oversee end-to-end data management activities within a clinical trial, as well as leading and coordinating global teams in a matrix organization.
Strong project management, communication, collaboration, and problem-solving skills. Ability to work proactively and independently on assigned tasks or projects of varying complexity. Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data management. Experience with clinical trial data standards, such as CDISC, is preferred.
YOUR MAIN BENEFITS:Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card. Work-Life balance: Enjoy additional paid days off, flexible working hours, and a hybrid working model. Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities. Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.
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