Clinical Research Medical Advisor

hace 5 días

Madrid, Madrid, España Indiana Biosciences Research Institute A tiempo completo

**About the Role**

From Strategy to Operational Excellence

The Clinical Research Medical Advisor provides clinical development and indication expertise specific to the Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines:

**Key Responsibilities**

  • 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.
  • 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 issues.

**Key Performance Indicators**

  • Meets 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.

**Requirements**

  • Scientific degree M.D., Ph.D., or Pharm.D. (M.D. is preferred)
  • Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice

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