Senior Clinical Data Manager

Oct 23, 2021

Job Description

Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients.

As the Senior Clinical Data Manager, you will lead all aspects of data management activities, drive innovative digital strategies for projects and ensure timely and quality data availability in order to facilitate data analysis and reporting for assigned studies/brands/medical units within US CDMA. You will be in support of complex clinical trials in phases III and IV by leading biometrics data operations strategy through collaborations across the organization. You have the opportunity to represent biometrics data operation strategy in different forums, maintain sound working relation with stakeholders, develop and mentor team members, provide strategic, technical and operational solutions to the organization leveraging expertise in science and technology

What you’ll be doing:
• Leads all facets of clinical data management related tasks for multiple studies across therapeutic areas but not limited to inputs into protocols, execution of Study Specification Worksheet (SSW), select and audit CROs, ensure quality and timely completion of data operations deliverables meeting KPIs and proactively maintaining documents audit ready by timely archival of data operation documents into document management systems.
• Develop and present CDM activities in investigator meetings, CRA workshops, and Project Kick-off meetings as appropriate.
• Monitor clinical data quality and progress of trials both in-house and outsourced to CROs; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.
• Ensure complete and consistent medical term coding in collaboration with medical teams using appropriate standard dictionaries; ensure consistency of serious adverse events data across clinical and drug safety databases.
• Act as project lead ensuring up-to-date and accurate tracking of study status, proactively identify and mitigate risks to ensure smooth and successful timely database lock. Escalate to biometrics leadership about risks and challenges as appropriate.
• Support biometrics leadership to Initiate, drive and implement innovative digital strategies, development of analytical dashboards across clinical studies in coordination with internal and external stakeholders.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

Minimum Requirements

What you’ll bring to the role:
• B.S. degree in life science, pharmacy, nursing, statistics, computer science or equivalent relevant degree with 8+ years relevant work experience.
• Expertise in performing data management tasks using electronic data management systems, for example, RAVE, Inform, etc), very good with MS Excel and SQL databases.
• Fluent in English (oral and written), strong interpersonal, presentation and communication skills.

• Good project management skills with attention to detail and quality focused.
• Strong knowledge of drug development and Health Authority guidelines. Thorough understanding of physiology, Clinical trial methodology, GCP, medical terminology and coding.
• Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates.
• Good business ethics.

You’ll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well.

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.

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
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:

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!
East Hanover, NJ
Research & Development
Full Time
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Senior Clinical Data Manager

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