Job Description Summary
Clinical Operations Program Manager
The ideal location for this role is our East Hanover, NJ site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific East Hanover, NJ site for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require minimum travel (1-2 trips per year).
About the role:
The Clinical Operations Program Manager (COPM) will provide operational support for clinical development programs and trials where there are early viability, feasibility, allocation and site selection activities to deliver. The scope of activities for this key role will range from early viability, feasibility assessment, validation and refinement of allocation strategy, including scenario planning and risk management, and any re-feasibility assessments, as applicable.
Your Key Responsibilities:
- Provide key support to conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials, in particular by providing:
- Preparation and coordination of briefing information, training resources and other materials
- Project planning support and follow-up / management of key deliverables
- Assist assembly of actions, output summary and minutes for follow-up tracking
- Lead aspects of the feasibility activity as needed - e.g., feasibility survey consolidation and analysis, review of data insights with feasibility teams, etc.
- Coordinate and manage the editing, technical support resolution and distribution of information gathering questionnaire for feasibility at trial level between sites, countries and global. Ensure feedback from feasibility assessment is addressed.
- Partner closely with the country feasibility team to align on the end-to-end quality of feasibility product
- Elaborate scenarios of geographic country footprint and proposed sites for participation in a clinical trial and supports COP(a)D, COPH a GCO sub-team on final site allocation.
- Contribute to the execution of the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the GCO sub-team
- Contribute to the development of risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation.
Minimum Requirements:
- Bachelors' degree in life science/healthcare.
- 3+ years of pharmaceutical clinical drug development experience
- 1+ year of experience in planning/execution global clinical trials
- Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.
- Possess resourceful research skills to locate unusual information and have capacity to develop a domain specific knowledge base.
- Demonstrated experience in feasibility for global clinical trials.
- Proven success in identifying, proactively flagging, and resolving risks; experience with strategic scenario planning and management.
- Ability to understand analytical data insights with proven ability to communicate background details and rationale.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range:
$130,400.00 - $195,600.00
Skills Desired:
Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Project Management
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