Clinical Research Medical Advisor (CRMA) at Novartis

Major Accountabilities:

• Oversees clinical program(s) across indications, executing medical strategy for development and marketed products in a defined therapeutic area.
• Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
• Is responsible for assuring aligned communication with Country/Cluster Clinical Research

Associates, Managers and other key stakeholders on the execution and progress of the clinical studies.

• Identify new sites for clinical trials; analyze capability and make recommenda-tion for trial inclusion.
• Facilitate preparation and collection of site level documents; resolve problems as required.
• May execute site initiation and training.
• Implement total site management including monitoring visits, regulatory assess-ment, drug supply management and resolution of site problems to ensure compli-ance.
• Track trial execution milestones; identify problems; resolve issues and escalate as
• May manage recruitment and execute contingency plans, as needed.
• Complete preparation/generation of study monitoring reports.
• May lead and chair local study team meetings, attend and participate in global clinical trial team meetings
• Reporting of technical complaints / adverse events / special case scenarios related to
• Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

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.

Minimum Requirements

• Medical or Scientific Bachelor Degree (preferred); Master in Science (beneficial);
• Has 3 years of validated experience in medical practice and fully trained in Drug Development including Clinical Research, GCP, local regulatory requirements has previous experience in Clinical Trials recruiting, identifying and advising researchers, identifying and evaluation Clinical Research Offices; ideally previous experience across different therapeutic areas ;
• Ability to lead a study from medical/clinical perspective and proven capability to problem seek; safety monitoring providing medical or scientific expertise in clinical trials; demonstrates a deep knowledge of how to adequately review and read a protocol to understand the design of clinical trial;
• Preferably working before in Pharma companies or with Pharma projects; Must have knowledge on ICH-GCP, international (i.e. FDA, EMA) and local clinical trials regulations and data privacy laws; experience working in multinational companies, with a matrix organization and cross board projects;
• Has excellent abilities to communicate, influence, persuade and negotiate with different teams and partners; Has high ethic and integrity skills; Looks always for Operational Perfection; Has the ability to seek problems and sophisticated issues; Has excellent teammate skills.