Associate Director (Group Head) - Clinical Database Delivery

Jun 15, 2021

Job Description

4^4 - The number of projects that you would lead or support across multiple therapeutic areas.
We are looking for an experienced professional with robust programming competencies (SAS, SQL, Python, R, etc.) & strong communication skills for our Clinical Database Development Reporting & Analytics function. As a member of this function, you would be primarily responsible for seamless end to end data flow of Clinical & Operational Data from Data Collection, Transformation , Reporting & Analytics & provisioning of data to downstream applications & teams.

Job Purpose
The Group Head of Clinical Database Delivery (CDD) is a leader with a thorough understanding of the drug development process and strong experience in regulatory requirements and Database Development deliverables including data transformation, external data loading, study SDTM modelling.
The Head will have a well-established track record of organizational leadership, supporting Novartis portfolio of products and therapeutic areas (including NIBR, Alcon Device and Sandoz)., in order to:
• Ensure all deliverables consistently meet high standards with respect to quality and timelines.
• Manage resource-needs for Clinical Database Delivery, ensure optimal usage of these resources to meet the needs of DM and its customers.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Drive business efficiency by ensuring the processes focus on achieving quality while remaining financially conscious and cost effective operationally. Anticipate internal and external drivers and opportunities to define and implement cross-functional strategies to maximize productivity and efficiency through use of effective business process, global corporate standards and utilization of strategic alliances with external partners.
• Co-ordinate the development and maintenance of all database deliverables across systems and ensuring these deliverables are on time and of high quality.
• Track and assign appropriate TA (responsibility can include more than one TA) resources in line with Company priorities in order to meet timelines for database delivery deliverables.
• Establish and maintain a high performing, industry recognized Database Delivery organization:
o Mentor leadership talent and high performing associates. Responsible for succession planning, performance management, training and professional development.
o Establish and steer business founded on innovation, collaboration, quality, customer service and trust.
o In collaboration with Human Resources, develop, establish and maintain up-to-date strategies to attract and retain top talent across the globe by maintaining a targeted recruitment strategy for key strategic positions.

• Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical Operations and Quality functions.
• Lead independently or participate in improvement initiatives and/or non-clinical projects
• Vendor and FSP oversight management.
• Ensures appropriate exceptions requests, deviations and corrective/preventive action plans are in place for corresponding processes, systems and deliverables.
• Propose creation of new SOPs, NIPs and WPs where appropriate, provide input to and undertake the implementation and maintenance of such documents and standards.
• Represent department at any DM and GDO meetings and provide timely feedback to DM partners and Clinical Database Delivery team.
• Support DO at Novartis by leading internally and externally; proactively lead, influence, collaborate and shape the external environment including regulatory guidelines, industry practices and professional organizations.

Minimum Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree in Life Sciences, Computer Science, Medical Informatics or equivalent with At least 10 years of Clinical Data Management experience in global drug development, within the pharmaceutical industry. 5+ year’s leadership experience - Global experience would be preferred.
• Significant relevant experience and knowledge in the Pharmaceutical Industry.
• Expert in regards to regulatory requirements relevant to Data Management and Statistical Programming (e.g. GCP, ICH).
• A demonstrated leader and expert in problem solving skills, and ability to evaluate computer systems for Data Management. Established leadership skills with a proven track record in leading and developing people, teams, operations, and innovation in complex global matrix structures and business models.
• Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.
• Good understanding of clinical database management systems and standards.
• Proven ability to proactively identify issues, recommend and implement solutions

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Global Drug Development
Hyderabad, AP
Research & Development
Full Time
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Associate Director (Group Head) - Clinical Database Delivery

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