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Novartis

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4.1

based on 1.5k Reviews

245 Novartis Jobs

Associate Director (Group Head), Clinical Data Acquisition & Mgmt

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.5k Reviews

10-15 years

Hyderabad / Secunderabad

1 vacancy

Associate Director (Group Head), Clinical Data Acquisition & Mgmt

Novartis

posted 3hr ago

Job Role Insights

Flexible timing

Key skills for the job

Medical Coding Project Management Clinical Data Management Recruitment US Staffing WPS

+ 2 more

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.

About the Role

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: