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Clinical Operations Program Manager

1 month ago

East Hanover, New Jersey, United States Novartis Group Companies Full time

About the Role:

We are seeking a highly skilled Clinical Operations Program Manager to join our team at Novartis Group Companies. This role will provide operational support for clinical development programs and trials, focusing on early viability, feasibility, allocation, and site selection activities.

Key Responsibilities:

  • Conduct end-to-end feasibility processes, including early viability assessments, pre-IMB and trial feasibilities, and strategic allocation, site selection, and recruitment plans.
  • Prepare and coordinate briefing information, training resources, and other materials.
  • Provide project planning support and follow-up management of key deliverables.
  • Assist in assembling actions, output summaries, and minutes for follow-up tracking.
  • Lead aspects of the feasibility activity, such as feasibility survey consolidation and analysis, review of data insights with feasibility teams, and coordination of information gathering questionnaires.
  • Partner with the country feasibility team to align on the end-to-end quality of feasibility products.
  • Develop scenarios of geographic country footprints and proposed sites for participation in clinical trials.
  • Contribute to the execution of the feasibility process by developing feasibility assessments, coordinating execution at the country level, evaluating prospective sites, and providing thorough analysis and summaries of feasibility outcomes.
  • Develop risk management strategies for clinical trials, highlighting feasibility-related operational risks and mitigation actions.

Requirements:

  • Bachelor's degree in life science or healthcare.
  • 3+ years of pharmaceutical clinical drug development experience.
  • 1+ year of experience in planning and executing global clinical trials.
  • Strong understanding of clinical drug development, particularly in clinical trial design, execution, and feasibility and allocation processes.
  • Resourceful research skills and ability to develop a domain-specific knowledge base.
  • Demonstrated experience in feasibility for global clinical trials.
  • Proven success in identifying and resolving risks, with experience in strategic scenario planning and management.
  • Ability to understand analytical data insights and communicate background details and rationale.

Novartis Compensation and Benefits:

The pay range for this position is expected to be between $130,000 and $195,600 per year. The total compensation package may include a sign-on bonus, restricted stock units, and discretionary awards, in addition to a full range of medical, financial, and other benefits.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are committed to building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds, and perspectives. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please contact us.