Job ID 320452BR Position Title Associate Director/Manager Data Operation Apply to Job
Job Description
1 purpose...to reimagine medicine! Novartis Institute of Biomedical Research or NIBR is the innovative internal pipeline engine (Targeted agents, Biologics, Cell and gene therapies, Radio Ligand therapies) of Novartis where 6000 associates are working across the globe. By joining NIBR you be working in a global and exciting research and development environment, fueling the pipeline through Proof of concept and reimagining medicine.
Based on our understanding of cancer at the molecular, cellular and organismal levels, Translational Clinical Oncology or TCO, will design and execute innovative exploratory clinical trials in order to develop the next generation of highly effective therapeutics that transform the lives of patients with cancer.
This role is to bridge the gap between data management and clinical team. Manage data managers in CRO and increase data management productivities to support the TCO portfolio efficiently.
The Associate Director/Manager Data Operation is responsible and accountable for managing all data management related deliverables at a consistently high standard with respect to cost, quality and timelines for high complexity TCO projects. The position is a key global leader with collaboration of study team in ensuring the planning, execution and close-out of the clinical trials across TCO portfolio. Act as data management expert and lead digital data review initiatives.
Your responsibilities will include:
• Proactively oversight data management related deliverables based on business needs
• Closely work with CRO management from recruitment, onboarding to manage the resources through operational excellence. Drive the increase of productivity
• Collaborate with Data Operation and clinical team in TCO CRF standardization, edit checks, and CCG
• Align with managers from database developer group and LSH programming group on process improvements related to data availability
• Provide digital data review strategies. Digitalize the data cleaning activities for both clinical and data management teams
• Participate or lead DART on cross-functional strategy initiatives. Represent DART at leadership forums, conference and functional societies
* Position will be filled at level commensurate with experience
Minimum requirements
What you'll bring to the role:
• BA/BS/MS or international equivalent experience in life science, information management, pharmacy, nursing or equivalent relevant degree is required
• Minimum 10 years’ experience in drug development with at least 8 years in Clinical data management or data operation
• Minimum 5 years' Project Management experience
• Expert Rave EDC experience and proven skills in the use of JReview, Patient Profile, Spotfire or other data visualization tools.
• Strong technical and problem solving skills, and ability to evaluate computer systems for Data Management.
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Proven communications and negotiation skills, ability to work well with others globally and influence
• Lead several complex studies/projects level activities, preferably in Oncology, including coordination of large team of internal or external TDM
Desirable:
• Knowledge of SQL, PL/SQL, VB script, SAS to develop edit check programming, debug, and execute code in the Clinical Data Management System is a plus.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#LI-NOV = Novartis Division NIBR Business Unit Oncology NIBR Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
