Associate Director

Job Description Summary

The Associate Director (Functional Lead) is accountable for facilitating and managing all Data Management domain related enterprise level strategic projects. This is a key leader position ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables. It is a leader role with a strong understanding of the drug development process with a track record of delivering.

To partner and support the functional mentors within the community to set up learning networks across all communities within CDAM. Work seamlessly with partner groups. Lead, contribute to and implement initiatives to establish and maintain Novartis Clinical Data Acquisition and Management as best in class in the industry.

Job Description

Major accountabilities:

• Co-ordinate activities of data managers either internally or externally. Make data management decisions and propose strategies at project or disease level.
• May act as a local manager of global associates including providing supervision and advise to these data managers on functional expertise and processes
• Build and maintain effective working relationship with cross-functional teams incl. Trial Management, Trial Monitoring and  Statistical Reporting counterparts, able to summarize and discuss status of deliverables and critical Data Management aspects impacting outcomes.
• Comply with company, department and industry standards (e.g. CDISC) and processes, ensuring data management innovations and foster data management solutions, ensure their efficient implementations and knowledge sharing within the project(s) or disease area.
• Maintain up-to-date advanced knowledge of industry software and reporting tools (e.g. Jreview/Spotfire) as well as industry requirements (e.g. CDISC SDTM/ADaM), attend functional meetings and trainings.
• Represent Data Management at audits and in Health Authority (HA) meetings for assigned project(s), or on data management aspects in external conferences or groups (e.g. SCDM).    
• Provide authoritative technical and professional recommendations as representative of the data management function at project level or for a major non-clinical initiative. Provide thought leadership level support and guidance.
• Develops risk management strategies to prevent data quality issues from derailing projects. Carries out lessons learned in order to feedback and further enhance the DM processes  
• Help with the recruitment of talent, coach and develop data managers. Leads/supports non-clinical special projects and initiatives like process simplification, automation, capability build.
• Provides subject matter expertise to special projects as needed
• Maintain external focus by interacting and influencing industry working groups and organizations

Key Performance Indicators:               

• Achieve overall goals as set each year by Global Head, Clinical Data Acquisition and Management (CDAM)
• All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures
• No critical audit findings due to Clinical Data Acquisition and Management
• Adequate representation of the Data Management function as Strategic Lead in the cross-functional forums and initiatives.
• Ability and effectiveness as a data management representative on major non-clinical initiatives.

Impact on the organization:

• Management of strategic deliverables impacting quality of study startups, high quality database locks affecting submission to Health Authorities in a timely manner
• Supports recruitment and retention of talent and effective development of staff
• Innovative technical solutions and enhancements, as well as standardization efforts ensuring timely and efficient drug development

Education (minimum/desirable):

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.       

Languages:

Fluent English (oral and written).

Experience/Professional requirement:

• 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
• 2+ years as a PDM including co-ordination of large team of internal or external data managers
• Ideally 10+ years' experience in Drug Development with at least 8 years' in Clinical Data Management Excellent verbal and written skills.

Skills Desired

Clinical Data Management, Cross-Functional Team, Data Architecture, Data Governance, Data Management, Data Quality, Data Science, Data Strategy, Drug Development, Master Data, People Management, Waterfall Model

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