A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
Think what's possible.
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.

