Jun 16, 2022

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.


Major Activities:
1. Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed

2. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.

3. Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards

4. Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)

5. Manage local lab set up for the Clinical Database as applicable

6. Performs DM hands on activities during the course of the study

7. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)

8. Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation

9. Supports and assists Junior staff for assigned trials

10. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner

11. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence

12. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).

13. Ensures adherence to regulatory requirements(ex., GCP), DM standards, SOPs/WPS and process guidelines

Why consider Novartis?

817million. That’s how many lives our products touch. 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.

We are Novartis. Join us and help us reimagine medicine.


Diversity & Inclusion / EEO


Minimum Requirements

Education (minimum/desirable):
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.

Fluent English (oral and written).

Experience/Professional requirement:
1. Ability to work under pressure demonstrating agility through effective and innovative team leadership
2. Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
3. Excellent problem solving skills
4. Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management
5. Excellent verbal and written skills
Global Drug Development
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Associate, Senior Clinical Data Manager

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