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Clinical Research Medical Advisor
hace 2 meses
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.
- Contributes to the 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:
- Proactively 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) 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 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.
