Band
Level 4
Job Description Summary
As a Clinical Research medical Advisor (CRMA) you will support one of designated therapeutic areas (Cardio-Renal-Metabolic/Immunology/Neuroscience). In this capacity you will be accountable for all country clinical/medical aspects associated with Development and prioritized Research programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. (This may involve work across several countries).It is a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs, aligning technical, operations & strategy.
CRMA’s gather, inform, and act on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation. They also drive the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.
Working in close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) you will actively contribute to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.
This position is part of the team CRMA GDD and reports directly to the CRMA Head Iberia.
#LI-Hybrid
Job Description
Major Accountabilities
Validates study designs and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Develops clinical/medical trial plans taking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation.
Supports and partners with internal Stakeholders and internal decision boards as needed regarding clinical trials, as the scientific/clinical/medical expert, (important internal stakeholders will be Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, Health Economics and Outcomes Research (HE&OR), clinical trial operations, etc.)
Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal Stakeholders at the Country/Cluster level with the goal to optimize clinical trial implementation.
Carries accountability for adherence to safety standards, clinical data quality for the Country/Cluster and provides general scientific/clinical/medical support for safety issues
Essential Requirements:
Scientific degree M.D., Ph.D., or Pharm.D. (M.D. is preferred), ideally with experience in clinical development within pharmaceutical industry or clinical practice.
Sound understanding of the overall clinical development process, and ICH/GCP principles.
Fluent English language skills (full proficiency in speaking and in writing)
Agility to move quickly across different therapeutic areas and indications as well as ability to prepare and deliver high quality presentations.
Desirable Requirements:
Subspecialty training.
Knowledge of Portuguese language.
You will receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Other Spanish standard benefits are Company Pension Plan; Life and Accidental Insurance; Meals, Allowance or Canteen in the office; Flexible working hours.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about 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.
Skills Desired
