Dirección
forma de trabajo Work Model: Hybrid
Locality: Mexico
About the Role:
• To provide clinical strategic and tactical leadership in the country/cluster to support Development and NIBR trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents.
• Closely collaborates with Clinical Operations and Medical Affairs team to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan.
• May lead medical/clinical discussion with local regulatory interactions as needed (CTA, NDA meetings, label discussions, post-approval commitments etc.).
• Cooperates with local functions such as e.g. Medical Affairs and Patient Access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to exploit the value of the assigned project(s) in the context of the investigational product(s).
• Drives implementation of innovative ways running clinical trials.
Key responsibilities:
Provide clinical development and indication expertise specific to a country and drives together with the local operations organization execution of clinical trials with high quality and in planned timelines:
• Closely collaborates with Clinical Operations to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local operational organization.
• Provides robust indication and protocol training to the clinical operations organization and other functions in the country/cluster as needed.
• Provide protocol, Risk management plan and disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed- back, etc.) and analysis of the competitive environment and competitive trials.
• Provide medical/clinical assistance to the operations organization and site for IEC/IRB Interactions.
• Review country or site specific Informed Consent Forms (ICF) and ensure accuracy of translation of information when translated into the local language, including the patient narrative where appropriate
• Support Ministry of Health interaction (or local Board of Health) as needed.
• Support Regulatory Affairs, Health Economics, Drug Safety and Epidemiology and Medical Information with medical/clinical input as appropriate as this relates to development clinical trials.
• Support planning, implementation and follow-up of regulatory agency inspections and internal audits.
• Review and resolution of local medical/clinical issues / questions – if necessary support the discussion of issues to global teams.
• Perform local AE review for development compounds and provide general medical support for safety issues:
o Provide medical expertise support to pharmacovigilance activities.
o Responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed.
o Follow-up with the Investigator for additional information or clarifications as needed.
o When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc.
• May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as representative in the Global feasibility team. Identify high quality local/regional datasets (e.g. registries) which could be used to drive innovative study designs or support recruitment.
• Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH and local regulations.
• Participation in early product planning process to ensure that trials are conducted to optimize cross- functional country strategy.
• Participate in global working groups in order to support and improve processes for the CD/CRMA line function.
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Key performance indicators/Measures of success
• Meet CO/Cluster specific KPIs targets, particularly those related to feasibility and recruitment.
• Prepare high quality study medical/clinical documents, according to agree upon timelines (usually < 1 week turn-around) especially IRB/EC submissions/queries.
• No critical findings in all audits related to the CRMA remit.
• Timeous management of safety issues.
• Quality of input to Global teams.
• Investigator support and satisfaction.
