Non Drug Program Associate Director

Job Description

Major accountabilities:

• Leads Data Mgmt activities for high priority/complex programs/projects -May act as local manager of global associates including providing supervision and advise to these data managers on functional expertise and processes -Accountable for all aspects of the Process and Training department to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved.
• Drive functional excellence by contributing to the definition of the strategic goals and operating policies, and leading/contributing to strategic initiatives in line with the overall strategy.
• May define SLA and negotiate with partners to establish optimal Statements of Work.
• Lead the development, collection, coordination and implementation of metrics for for both internal associates and external (CRO, FSP) resources and activities.
• Represents and drives Quality and Compliance organization -Manages and measures organizational quality.
• Ensures appropriate exceptions requests, deviations and CAPA plans.
• Build and maintain effective working relationship with cross -Representative at project-level and in the Submission team, or in local leadership team.
• Esnures compliance with company, department and industry standards/processes, -Oversees and is responsible for quality control and audit readiness of all assigned data Mgmt deliverables as well as accuracy and reliability of data within databases of assigned project(s).
• Maintain up-to-date advanced knowledge of industry software and reporting tools as well as industry requirements -Represent Data Mgmt at audits and in Health Authority (HA) meetings for assigned project(s), or on data amangement aspects in external conferences or groups -Mentors others to develop their own leadership capabilities and identifies/develops talent -Selects, recruits, develops, manages, motivates, coaches, develops talent and appraises the performance of direct reports to ensure high quality performance across his/her Clinical Data Mgmt Group -Leads and supports clinical and non -clinical special projects and initiatives -Propose creation of new SOPs, NIPs and WPs where appropriate, provide input to undertake implementation and maintenance of such documents , standards.
• Provide necessary help and support to address and resolve issues, Identifies solutions for remediation.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Data Mgmt activities and deliverables.
• No critical audit findings due to Data Mgmt -Effectiveness of participation in internal and external networks/initiatives.
• Effectiveness of recruitment, retention and development of talent.
• Efficiency of resource usage.
• Adequacy of resource estimation.
• Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction

Minimum Requirements:
Work Experience:

• Cross Cultural Experience.
• People Leadership.
• Project Management.

Skills:

• Clinical Data Management.
• Cross-Functional Team.
• Data Architecture.
• Data Governance.
• Data Management.
• Data Quality.
• Data Science.
• Data Strategy.
• Drug Development.
• Master Data.
• People Management.
• Project Management.