The Feasibility Manager is accountable for the oversight and coordination of program and study level (re-)feasibility assessments in the country or extended country group (OPCs & satellite countries), in collaboration with program and/or trial feasibility teams, in compliance with Novartis processes, GCP, ICH and regulatory requirements. This position is key to establish good communication and professional relationships with clinical investigators and company stakeholders on country/cluster/hub/global level.
Closely collaborates with rest of Study & Site Operations and relevant medical/clinical functions to ensure successful allocation, realistic country targets, recruitment according to planned timelines, early identification of risks and opportunities as well as potential delays and mitigation plan.
Your responsibilities will include but are not limited to:
• Single point of contact for communication between Clinical Operations Program Manager/Clinical Operations Program Head, country/extended country group Study & Site Operations teams and local relevant medical/clinical functions for all requests for program/study feasibility
• Coordinates the feasibility activities on country/extended country group level by ensuring:
• Coordinates the feasibility activities on country/extended country group level by ensuring:
o Site identification and selection, trial feasibility evaluation
o Collates/validates the list of potential sites by utilizing internal and external data (e.g., historical data, individual knowledge within local Study & Site Operations Team and relevant medical/clinical functions, internal and external databases)
o Manages the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable
o Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained
o Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment
o Enters feedback into global database if applicable (e.g., CLIP).
• Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country / extended country group allocation of clinical programs and assigned trials
• Responsible for early identification for potential risks and opportunities as well as potential synergies and back-up strategies within the country/extended country group
• Closely collaborates with the Study & Site Operations to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the Study & Site Operations organization.
Cooperates with local functions such as GDD CRMA, Medical Affairs, Patient access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to exploit the value of the assigned project(s) in the context of the investigational product(s).
• Close collaboration with Clinical Project Manager, SSO Study Start-up Manager & SSO Site Partnership Manager and relevant medical/clinical functions in the planning, execution and delivery of their assigned studies / accounts
• As needed involves SSO Portfolio Team Lead/SSO Portfolio Country Head for discussion on the final feedback, e.g., country/extended country group commitment sites/patients and timelines and potential recruitment barriers
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
Minimum requirements
What you will bring to the role
• Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable
• Minimum 5 years’ experience clinical development experience in pharmaceutical industry
• Capable of leading in a matrix environment, without direct reports and working cross-border
• Ability to lead a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues
• Agility to adapt quickly across different therapeutic areas and indications
• Strong project management capabilities
• Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial
• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care
• Ability to assess the feasibility of implementing the protocol based on regional medical practice and sound understanding of the overall clinical development plan
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
#GCO
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
US Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] 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.
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.
The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800 annually; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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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