Have you ever imagined how does your work impacts society and how many lives can you improve through your daily activities?
1000 million is the number of patients that Novartis Worldwide touched in 2017. Through innovative Access Strategies, Novartis Mexico has signed 14 agreements with Healthcare Institutes to provide High Specialty treatments to patients for improve and long their lives.
The purpose of this position is to be accountable for planning, executing and reporting on a number of Medical Affairs clinical studies for a country or cluster, from planning and site feasibility through study close-
out, in compliance with Novartis processes and regulatory requirements, under direct supervision of Clinical Research Medical Affairs Manager;
In addition, this position will maintain certain MACRA activities in some percentage;
This position is key to good communication and professional relationships with clinical investigators and international colleagues in HQs and CPOs;
To maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel;
In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country / cluster;
To ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB / EC submission packages, working with regulatory affairs for Health Authorities submissions;
To monitor the status of site budget and contract negotiations as well as the collection and review of essential documents;
To ensure sites are prepared for Ready to Initiate Site (checkpoint). Obtain written confirmation about availability of global documents;
To ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person;
To provide training as needed for monitors and any other activities that support site readiness to recruit;
To drive the conduct of the trial, track and oversee progress and status;
To appropriately escalate issues in a timely manner and ensure resolution;
To communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics;
To lead and chair local study team meetings, attend and participate in global clinical trial team meetings;
To become accountable to keep reporting systems up to date : ClinAdmin, TMF, CREDI... throughout trial conduct;
To be consistently reading / reviewing the content of all monitoring visit reports for the assigned trial;
To contribute to the identification of new sites for clinical trials; analyze capability and make recommendations for trial inclusion in CAC region;
To implement comprehensive site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance;
To act as Local or Global Lead CRA in a given clinical trial and be the author of the global monitoring plan;
To act as mentor for new associates and provide functional training, upon trial specific appointment;
To perform initiation, monitoring, remote and close out visits in sites.
Why consider Novartis? :
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.
Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Must have a Scientific of Healthcare Degree or adequate equivalent;
Must have at least 3 years of experience doing on time the submission of clinical trial results;
Must have experience supporting product approval and commercialization in country / cluster;
Must have experience to ensure that the studies are executed according to internal and external standards and regulations;
Must have experience working with the brand reputation as credible, ethical and preferrefed partner in maintained / enhanced willingness from investigators;
Preferably working before in Pharma companies or with Pharma projects;
Must wanted to add value with his / her work;
Must have experience and knowledge with the Healthcare Systems procedures and guidelines;
Has excellent abilities to communicate, influence, persuade and negotiate with different teams and stakeholders;
Has high ethic and integrity skills;
Looks always for Operational Excellence;
Has the ability to solve problems and complex issues;
Has team player skills;
Willing to travel constantly;
Advanced Spanish skills (written, reading and speaking);
Advanced English skills (written, reading and speaking).