Job Description

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO

Oversight of CRA performance, development and coaching of CRA to drive mindset and behavior- responsible for managing and addressing CRA performance targets per defined KPIs: delivery, productivity, and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution.

People and resource management – ongoing assessment of allocation of CRAs to studies and sites.

Budget oversight – monitors and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure local targets for travel budget are met.

Ensures CRA monitoring competency gaps are identified and resolved through targeted coaching and training curricula in collaboration with training... group.

Liaise on ongoing basis with CPMs to ensure enrollment, data collection and data cleaning are executed by CRAs in a timely manner.

Your responsibilities include, but are not limited to:
• In collaboration with SSO CPM, supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities and trends that require targeted training and/or development of CRAs to deliver to trial and quality KPIs;
• Is accountable for monitoring quality, timely data entry, issue resolution and competency gaps. Resolve through targeted training curricula in collaboration with training group as well as by performing co-monitoring visits with training purposes;
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, always ensuring human subject protection and reliability of trial results. Supports Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site identified issues;
• Actively manage CRA team performance including implementation of development and performance improvement plans. Is responsible for execution of annual CRA oversight visit plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies;
• Supports implementation of Risk Based Monitoring in GCO clinical trials by coaching and training CRAs on process thinking, risk-based monitoring concept and related systems and ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements;
• Manages CRA adherence/compliance to SOPs and required training curricula. Performs ongoing assessment and allocation of monitoring resources within countries to ensure balanced CRA workload for quality monitoring;
• Is responsible for the hiring, training, development, and retention of a team of CRAs executing Phase I-IV Global Drug Development (GDD) trials;
• Ensures CRAs have the required level of monitoring and disease area knowledge and skills to successfully deliver to protocol requirements. Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy and budget.

This position is eligible to hybrid working principles.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

Required Experience & Qualifications:
• A degree in scientific or health discipline required and advanced degree preferable
• Fluent in both written and spoken English and Spanish;
• Very solid experience in clinical research - planning/executing and/or monitoring clinical trials
• Experience in project management and evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.

Desirable Experience & Qualifications:
• Decision making capability and excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, risk-based monitoring and Novartis standards

#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!

Accessibility and accommodation

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para desempeñar las funciones esenciales de un puesto, envíe un correo electrónico a [email protected] y permítanos conocer la naturaleza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

Global Drug Development

Business Unit

GCO GDD

Country

Mexico

Work Location

Estado de Mexico

Company/Legal Entity

NOV CORPORATIVO MEX

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No
Mexico City CDMX Mexico

Salary Criteria