Associate Director, Data Operations, Clinical Data Management

Job Description Summary

The Associate Director / Group Head will lead a community of 20 Clinical Data Acquisition Specialists, Clinical Data Scientists and Coding Specialists as assigned to individual therapeutic areas (TA) responsible for ensuring adequate staffing/resource allocation for delivery of the portfolio to the TA area (managing attrition, hiring, talent retention); people management/career development, employee engagement of the community. Facilitate the sharing of resources between groups to meet company goals and objectives.
Furthermore, will partner with Senior Group Head in contributing towards the TA-community’s goals and KPIs (quality, cost, cycle-time and productivity). To partner and support the functional mentors within the community to set up learning networks across all communities within Clinical Data Acquisition and Management (CDAM). Work seamlessly with partner group to lead, contribute to and implement initiatives to establish and maintain Novartis CDAM as best in class in the industry

 

Job Description

Major accountabilities:

• Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports to ensure high quality performance across their community of Clinical Data Acquisition and Management associates/roles (Clinical Data Scientists, Clinical Data Acquisition Specialists and Coding Specialists)
• Facilitates a partner and customer oriented Clinical Data Acquisition and Management group, role modelling behaviors for the associates within their community as per the Novartis Values and Behaviours.
• Accountable for the assignment of resources and workload within his/her community, and ensures sharing of resources between groups in order to meet company objectives and priorities
• Partners with the functional mentors within own community and Functional Experts within CDAM to ensure associates are empowered and able to take the right decisions to solve issues at the trial/program delivery level.
• Understands Health Authority requirements and is able to participate in Health Authority inspections as required
• Builds and establishes a strong team spirit and creates a team founded on technical ability, excellence in performance and exhibiting the Novartis values and behaviours
• Leads/supports non-clinical special projects and initiatives. Provides subject matter expertise through self/through team to special projects as needed
• Highlight the need for training programs and support the establishment of these (technical and professional skills) for Clinical Data Acquisition Management team members.
• Ensures high quality communication and information flow on status of trials to stakeholders, mitigates and manages risks
• If required deputizes for the Senior Group Head of Clinical Data Acquisition and Management as required
• Maintain external focus by interacting and influencing industry working groups and organizations

Ideal Background

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Proven leadership, collaboration and organizational skills with relevant experience within Clinical Data Management / Clinical Data Science environment
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Ideally 10 years’ experience in Drug Development with at least 6 years' in Clinical Data Management with at least 5 years line management or leadership experience

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

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