US-NJ, Senior Regional Operations Manager - East Hanover, NJ 214857BR-MZ
Senior Regional Operations Manager - East Hanover, NJ
Global Drug Development
East Hanover, NJ
Research & Development
These roles are all in NJ and are East Hanover campus-based.
No relocation assistance is provided. Locals only, please.
The Sr. ROM is responsible for clinical operations activities and timely completion of assigned clinical trials (ranging from Phase I to IV) within the Region, in alignment with Region Head Trial Monitoring, in collaboration with Trial Operational Managers (TOM) and Clinical Study Managers (CSM) in the Countries, in compliance with Novartis processes, GCP, ICH and local regulations.
The Sr. ROM is responsible for comprehensive portfolio situation analysis and decision making - in close collaboration with Region Head, Trial Monitoring - to ensure effective performance within the region. These activities include strategic and operational planning, allocation and feasibility in close collaboration with Region Head, Country or Cluster Head of Trial Monitoring and Country Medical. In addition, is responsible for coordination of start-up activities, patient recruitment, and clinical data collection progress working closely with Country CSMs. Contributes to the implementation of the Trial Monitoring strategy in the Region. Contributes to the achievement of productivity targets (ex: maximize Regional productivity).
Trial Monitoring strategy
In collaboration with the Trial Monitoring key stakeholders (Regional, Country and Cluster Head, and TOMs) and Medical Director/CSO, assists in the development of regional trials execution plans and timeline commitments to achieve global and regional/local business objectives
Participates in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement initiatives to ensure the delivery of assigned studies on time
Ensures awareness and integration of regional strategic plan within the assigned TOM Development Unit. Is responsible for the consolidation, analysis, balance, and delivery of regional level allocation, as well as, patient recruitment plans and clinical data updates
Delivers timely progress reports and ad hoc updates to Regional, Cluster, Country Trial Monitoring and Regional Medical/CSO
Serves as core member of the assigned TOM Development Unit Team. Represents the Region, Cluster, Country within TOM Development Unit Teams
Participates to the development of reporting methodologies, and implements regional performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems (i.e ClinAdmin, DARWIN). Supports the Region, Cluster or Country Head Trial Monitoring with clinical trial and project/Development Unit update
Allocation, initiation and conduct of trials
Is responsible for reporting trial execution according to enrolment commitment and timelines, per established regional key performance indicators
Supports the optimal utilization of regional opportunities to build competitive advantages for global development trials within the Region taking into account medical standard of care, competitive environment and local business drivers
Is responsible for operational risk assessment and mitigation planning in coordination with country CSM, Development Unit Head or Country Head to ensure operational aspects of study delivery (allocation through study close out) on track to plan
Is accountable to lead trial allocation and feasibility process within the Region, Cluster, Country to ensure adequate patient accessibility and alignment with regional and country strategies, including the regional re-allocation or corrective action when needed. Manages the Country selection in collaboration with Region Head Trial Monitoring and Country Medical/CSO
Is accountable for coordination of ongoing oversight of allocation targets, in collaboration with TOM, Region, Cluster, Country Head Trial Monitoring and Medical Director/CSO to ensure delivery to regional and country allocation commitments
Collects and manages input to the study protocol. Evaluates potential challenges/risks and partners with CSM, County Medical/CSO to develop risk management plans
Reports Regional/Country progress of study start-up activities within the region, as required, in collaboration with Trial Monitoring stakeholders (CSMs and TOMs)
Reviews enrolment within the Region and at Country level, including responsibility for obtaining global approval of countries request to change recruitment commitment
Supports delivery of clinical data collection targets within the Region, Cluster, Country - as appropriate, including communication of timelines for database lock milestone deliverables, in coordination with Trial Monitoring stakeholders (CSMs and TOMs)
Monitors Countries and Regional performance for proper escalation action on data flow activities, and as needed, supports corrective action plan implementation
Tracks that all study close out activities are performed in a timely manner, in collaboration with TOMs, CSMs and key study stakeholders
Delivery of quality data and compliance to quality standards
Ensures quality of Regional, Cluster, Country feasibility responses as evidenced by completeness, timeliness and alignment to Regional, Cluster, Country disease strategy
Proactively applies diagnostic expertise to analyze and identify potential improvements across the region specific to trial feasibility, allocation and enrollment. Supports TOM in data flow management, as appropriate. Participates in and/or leads multidisciplinary taskforces to support continuous
Mentors new ROMs in all aspects of their role and provides training support to ROM group in function of their expertise on operational processes
Supports mentoring of new TOMs in aspects of their role related to collaboration with ROMs/Sr. ROMs
Supports the delivery of the region Trial Monitoring productivity initiatives and targets (ex: maximize regional productivity)
Identifies global or regional initiatives, tools or process improvements to deliver study allocation, feasibility and trail enrollment efficiencies
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor degree is required, preferably in a life science.
Advanced degree is a plus.
8+ years experience of related experience in clinical research including planning/executing and/or monitoring clinical trials
Demonstrated ability to collaborate across partner functions and capable of leading in a matrix environment, without direct reports, but can coordinate the activities of others
Thorough understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
Excellent understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
Understand and apply medical and business knowledge to clinical trial execution
Skills & Knowledge:
Excellent negotiation and communication/ relationship management skills
Excellent organizational, interpersonal skills with extensive networking experience
Developed influencing and facilitation skills
Communicates effectively with senior leaders in a local/regional/global matrixed environment
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