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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us the most rewarding employer in our field.


Clinical Trial Transparency Operations Manager


Business Unit:General Medicines
Division:Pharmaceuticals
Company/Legal Entity:USA Novartis Pharmaceuticals Corporation, East Hanover, NJ
Work Location:United States - New Jersey
Posting Functional Area:Development
Job Type:Full Time
Employment Type:Permanent
Job Reference Code:57130BR


Job Description:

Implement processes, monitor and track compliance of the Novartis policy for clinical trial and results registration (e.g. Data Disclosure policy).

- Maintain solid understanding of external influences/regulatory requirements for registering clinical trials and results.
- Develop and maintain standard operation procedure(s).
- Develop compliance reporting process, and ensure corrective action is taken for any non-compliance issues.
- Monitor and communicate compliance of clinical trial and results registries against the Novartis policies.
- Develop and manage internal and external audit plans.
- Develop and organize training sessions, "road shows", internal and external communications for relevant policy implementation.
- Build and maintain effective cooperative relationships with all internal and external stakeholders relevant to specific policies.
- Represent Novartis to external stakeholders regarding disclosure of clinical trial and results registries, e.g. DIA working group.
- Identify issues and drive solutions with internal stakeholders.
- Driving the development and implementation of IT solutions to support the compliance to the policy.- Scientific degree or extensive practical experience in a healthcare-related field, or scientific, technical or regulatory aspects of drug development.
- Strong time and project management skills.
- Excellent communication, listening, and technical writing skills.
- Analytical and critical thinking skills; decisiveness.
- Proven leadership skills in a responsible position in Clinical R&D, Project Management, Regulatory Affairs, or related areas.
- Proficiency in the principles of Good Clinical Practice and medical Ethics.
- Strong interpersonal and influencing skills and an ability to communicate to a very high level, both verbally and in writing; including the abiility to produce concise and informative executive summaries for senior management.
- Proven ability to influence, without necessarily having the referent authority.
- Self-motivated individual, who can work autonomously when required with a minimal need for daily management direction.
- Ability to adapt to changing external environment.

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