The Senior principal data manager is responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality and timelines for all assigned indications within one or more Global Clinical Program(s) / Project(s).
Coaches TDMs to provide leadership to project / study teams Ensure consistency across assigned program to aid efficiencies for submissions Provide active and effective communication to DMLT, Global Program teams, DO DUs and other stakeholder groups.
Provides Data Management leadership for one or more assigned programs / projects or indications. Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i : e ensuring consistency across data quality plans.
Develops an understanding of CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards.
Communicates and negotiates effectively with all other Program.Achieve overall goals as set each year by Global Head, Data Operations, GDO.
All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures.
No critical audit findings due to Data Management.
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).
Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines.
Excellent understanding of clinical trials methodology, GCP and medical terminology. Must be able to anticipate challenges and risks and proactively suggest / implement solutions.
Ability to work under pressure demonstrating agility through effective and innovative team leadership. Excellent interpersonal skills and proven ability to operate effectively in a global environment.
Ability to influence and communicate across functions and to external stakeholders. Ideally 8 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management.
Understanding of project management concepts in order to aid delivery across a program. Excellent verbal and written skills.