Associate Director (Group Head), Clinical Data Acquisition and Management (Clinical Data Science)

Job Description Summary

To lead a community of ~ 20 Clinical Data Acquisition Specialists, Clinical Data Scientists and Coding Specialists as assigned to TA area. To ensure 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 in order to meet company goals and objectives. To 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 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 Activities                                                                                  

• 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 associates and ensure their training is conducted and properly documented. To ensure all training needs for their community are addressed, and training compliance of their associates is maintained.
• Ensures high quality communication and information flow on status of trials to stakeholders, mitigates and manages risks
• Ensures that associates in their community are tracking time in the time-sheet in order to evaluate business needs with regard to capacity forecasting and increasing productivity
• 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

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

Job Dimensions

Number of associates:

15-20

Financial responsibility:

Control of direct reportees expenditure

Impact on the organization:

• Efficient use of resources through operational effectiveness on trial/program delivery
• Recruitment and retention of talent effective development of associates in the community  
• Ensure the achievement of assigned portfolio per the set KPIs for cost, quality and cycle time and productivity  
• Participates or leads non clinical initiatives

Ideal Background

Education:

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

     

Languages:

Fluent English.

Experience/Professional requirement:

• Proven leadership, collaboration and organizational skills with demonstrated 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 10 years’ experience in Drug Development with at least 6 years' in Clinical Data Management
• At least 5 years line management or leadership experience

 

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