Senior Data Manager, Clinical Data Sciences

ROLE RESPONSIBILITIES

• Serve as Lead Data Manager for one or more clinical trials assuming responsibility for DMM activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.
• Independently lead the daily DM activities and allocate study DM resource in the appropriate way.
• Coach junior Data Managers in the study and perform peer review of study DM’s deliverables for quality control.
• Be responsible to achieve the study DM milestone on time with good quality.
• In collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables.
• Ensure work carried out in accordance with applicable SOPs and working practices.
• Ensure the required study specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Ensure operational excellence in collaboration with CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.
• Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross study learning.
• Be capable to contribute on the DM related continuous improvement activities

QUALIFICATIONS

• Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP
• Demonstrated knowledge of data management processes and principles in area of responsibility.
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
• Demonstrates strong verbal and written communication skills including ability to communicate remotely
• Minimum 7 years Data Management experience required
• Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Proficient experience using commercial clinical data management systems and/or EDC products (e.g., Inform preferred)
• Experience using data visualization tools (e.g. Spotfire, J-Review) preferred
• Familiarity with MedDRA/WHO-Drug
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Bachelor’s degree minimum requirement.
• Experience of project management skill in terms of resource management and timeline and quality control preferred.
  

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