Job Title - Senior Clinical Data Manager I
Career Level - D1
Assist with coordination the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards and technology. May be member of the Global Study Team (GST) for less complex studies. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of an experienced Study Data Manager.
Typical Accountabilities
• Study level CDM operational support 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 (Key Performance Indicators) and project timelines.)
• Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level.
• Day to day responsibilities may include but are not limited to
o Study status reporting to the relevant clinical study team members, (e.g., provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.)
o Collaboration with Data Management Vendor/Study Data Manager regarding upcoming deliverables and milestone achievements (i.e., snapshots, interim, and migrations).
o 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 studies; Responsible to identify risks and collaborate with the 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 studies.
• May provide input to the selection and use of software systems, devices, and vendors.
• Responsible for compliance with 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 studies.
• 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 CDM related ad-hoc requests from Line Manager
Education, Qualifications, Skills and Experience
Essential
University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• End to end 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 leading studies, 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.
Desirable
Demonstrated knowledge of clinical and pharmaceutical drug development process
• knowledge 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.
• Knowledge of SQL, 4GL, VBA or R Programming.
Key Relationships to reach solutions Internal (to AZ or team) External (to AZ)
• Clinical Data Management Teams
• Statistical and Clinical Programmers
• Statistician
• Clinical Colleagues
• Clinical Quality Assurance and Compliance
• Core Team/Extended Study Team Members
• Patient Safety Team
• Biometrics operations
• Third party vendors that support Data Management including CROs
• Vendors conducting Patient Safety
Date Posted
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.