Senior Principal Clinical Data Manager

Responsibilities

• Project level CDM administrative support for project(s) based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start up, conduct and closeout phases. (i.e.,Documentation review and/or creation, User Access Testing, query management, data cleaning and reviews,third party data reconciliation in accordance with the project study model, KPIs and project timelines.)
• Day to day responsibilities may include but are not limited to: A) Study status reporting to the relevant clinical study team members, (e.g. provide data to R&D clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.) B) Collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements (i.e., snapshots, interim, and migrations). C) Oversight of the data quality, documentation quality, and types of these deliverables and milestones.
• Assist with coordination in the Clinical Data management deliverables on assigned projects depending on the relevant model and DM Vendor.
• Oversight of the day to day operational aspects of CDM for assigned projects; Responsible to identify risks and collaborate with the Principle Clinical Study Data Manager to mitigate the risk.
• Understands therapeutic area, indication or program specific data capture standards and AZ standards.
• Provide input into CDM related activities associated with regulatory inspections/audits for assigned project(s).
• May provide input to the selection and use of software systems, devices and vendors.
• Responsible for compliance to Trial Master File requirements relating to DM Vendor.
• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned project(s).
• Maintain an awareness of the external and internal models in order to flag for continuous improvement related to CDM operating models.
• Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
• Mentoring junior Clinical Data management colleagues.
• Performs any CDM related ad‐hoc requests from Line Manager or superior.
  
  

Education, Qualifications, Skills And Experience

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
• Knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
• Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
• Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
• Demonstrate understanding and experience in query management process and reconciliation activities
• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
• Excellent written and verbal communication skills
• Ability to work in a global team environment
• Excellent organizational and analytical skills and high attention to detail
• Demonstrated knowledge of clinical and pharmaceutical drug development process
• State of the art understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
• Demonstrated understanding of clinical data system design / development / validation and system interoperability.
• Demonstrated ability to work effectively with external partners
• Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
• Knowledge of SQL, 4GL, VBA or R software
  
  

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

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