CLINICAL RESEARCH MEDICAL ADVISOR

SummaryAs a Clinical Research medical Advisor (CRMA) 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.About The RoleFrom Strategy to Functional ExcellenceMajor AccountabilitiesThe CRMA Provides Clinical Development and indication expertise specific to Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines:Validates study designs, is accountable for, 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, which includes:Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans.Building disease area expertise, especially for new/rare indications.As the scientific/clinical/medical expert, supports and partners with internal Stakeholders (e.g., Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, Health Economics and Outcomes Research (HE&OR), clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.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.Accountable for adherence to safety standards, clinical data quality for the Country/Cluster and provides general scientific/clinical/medical support for safety issuesKey performance indicatorsMeets Country/Cluster specific clinical trial operations Key Performance Index (KPI) targets, particularly those related to trial feasibility and recruitment.Drives investigator site performance by providing high quality support to Investigators/Clinical trial site staff for Development and Biomedical Research studies, leading to a superior customer experience.Prepares high quality Country clinical trial documents according to agreed timelines especially for IRB/EC/Regulatory Authorities, and Investigator queries as needed.Essential RequirementsScientific degree M.D., Ph.D., or Pharm.D. (M.D. is preferred) with ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice.Sound understanding of the overall clinical development process, and ICH/GCP principles.Spanish, and ability to speak and writes EnglishAbility to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.Ability to lead effectively by communicating well, motivating a cross-functional team, and handling and delegating responsibilities.Agility to move quickly across different therapeutic areas and indications.Demonstrated problem-solving skills and comfort with complexity.Ability to prepare and deliver high quality presentations.Desirable RequirementsSub-specialty trainingWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards