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Clinical Research Medical Advisor
hace 2 meses
Overview
The Clinical Research Medical Advisor plays a crucial role in providing clinical development and indication expertise specific to Country/Cluster, driving 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.
- 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 issues.
Performance Metrics
- 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) 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.
- The ability to speak and write in English.
- Ability 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.
- Subspecialty training.
