Clinical Operations Program Manager

2 weeks ago

East Hanover, United States Novartis Full time

**Summary**:
Onsite - East Hanover 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.

**About the Role**:
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.

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,00 - $195,00/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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