Associate Director

Our number 1 priority is to serve people, communities, and patients by pioneering patient access to better healthcare. It’s our purpose that drives us; that inspires us; that challenges us. And that’s why we will never give up

TCO is a dynamic group of Clinical Trial Leaders who plan and execute Novartis' early phase global clinical trials. Based on our understanding of cancer at the molecular, cellular and organismal levels, TCO will design and execute innovative first-in-human clinical trials, in order to develop the next generation of highly effective therapeutics that transform the lives of patients with cancer.
You will be 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. This 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:

- Establish a partner and customer-orientated team under Clinical Operations. Represent Data Analytics and Review Team at cross-functional forums, meetings and provide timely feedback to partners.
- Provide input to and undertake the implementation and maintenance of global working practices and standards. Contribute to the development of the DART through his/her global leadership role
- Assign, track and request appropriate resources within the group in line with organizational priorities in order to meet timelines for DART deliverables.
- Ensure PCDM utilizing existing data review tools (JReview, Patient Profile, ICRS and new tools) at the on-going basis from the beginning of the trial. Ensures appropriate tracking systems are kept up to date.
- Develops strong across TCO portfolio level standards (e.g. Protocols, DHPs/DRPs & eCRFs/CCGs) and assure adherence across TCO projects and trials.
- Align with clinical operations and clinical programming groups to contribute effectively to development of TCO CRF standards and accompanying metadata, validations, CCGs, edit checks, etc.
- Provides data deliverables and data review leadership for internal or external PCDM. Provide guidance in the study start-up, conduct & finalization for data deliverables activities. Manages effective execution of data deliverables activities across programs.
- Provide guidance to efficiently monitor for data trends that would be signals of potential fraud/misconduct, previously unrecognized quality concerns, or a sign of slippage in some aspect of study management.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

What you will bring to the role:

- BA/BS/MS or international equivalent experience in life science, information management, pharmacy, nursing or equivalent relevant degree
- Ideally 10 years’ experience in drug development with at least 8 years in Clinical data management or data operation
- At least 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
- Lead several complex studies/projects level activities, preferably in Oncology, including coordination of large team of internal or external TDM
- 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?

769 million. That’s how many lives our products touched in 2020. 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

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
**Division**

NIBR

**Business Unit**

Oncology TCO NIBR

**Country**

Switzerland

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Research & D