CRMA

Job description

Job Description

Responsible for Development Clinical Trials from the medical/scientific point of view, integrating insights from internal and external stakeholders, in order to perform an adequate country and protocol feasibility. Provide a high level of medical expertise in the area of Clinical Drug Development to ensure the alignment to the Clinical Development Plan and the appropriate feedback to cover the CPO business priorities and early product planning Cooperate with Medical Affairs colleagues to identify and involve investigators and key medical experts in order to exploit the value of the assigned project(s) in the contest of the investigational product(s).

Provide medical expertise specific to the country for Clinical Drug Development and Clinical Operation activities • Lead and/or perform protocol, country and site feasibility. Provide consolidated feasibility and site selection input to global teams • Provide protocol & disease training as appropriate at Investigator’s Meetings, scientific venues and internal stakeholders. • Review and try to resolve local medical issues/question management that arise during the entire course of the study through physician to physician contact – if necessary transferring issues to global teams • Provide medical expertise to Clinical Operations activities when necessary, this may include the performance of local AE review and provision of general medical support for safety issues, safety amendments, investigator notifications, etc. • Ensure accuracy of translation of medical information related to clinical trials when translated into the local language, including the writing/validation of the country specific Informed Consent Forms (ICF), endpoints, AEs, SAEs and patient narratives. • May be called upon to provide strategic medical input into 2. Support ICRO and Global teams in the interaction with regulatory agencies • Provide assistance to ICRO and site for IEC/IRB Interactions • Support planning, implementation and follow-up of regulatory agency inspections and internal audits 3. Support Early Product Planning Team (EPPT), Drug safety and epidemiology (DS&E), Medical Information, Regulatory Affairs and Health Economics with medical input as appropriate as this relates to clinical trials.Participate in activities related to pharmacovigilance system as appropriate, report of adverse events, patient-oriented management , implementation of risk management plans and Pharmacovigilance training programs as applicable

Desired profile

Minimum requirements

Scientific degree (medical degree highly desirable). • Experience in medical practice and fully trained in all aspects of drug development including clinical research, GCP, data privacy laws ·         Fluent English (oral and written) • Speaks local language (if other than English) 1.  Experience in Pharmaceutical industry 2-3 years 2.