.About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader.Key Responsibilities Medical responsible for assigned projectsMaintains clinical oversight and quality on their trials and deliver according to study targetsSpecific medical/safety monitoring activities, ensuring compliance with ethical, legal, and regulatory standardsConduct clinical trials according to ICH GCP, local regulations, study protocol and company PNTsComply with environment, safety and health regulationsMaintain strict confidentiality on all information provided work with agreed clinical development plansWork closely with colleagues within R&D; and innovation Department, and other areas if required by the specific assigned projectsWrite protocol, and review CRDs, medical monitoring plan, Safety plan and other documents related with the medical responsibilities of the clinical trialWrite and review Informed consent documentationWrite and review Clinical study reports, Investigational brochures and other documents related with the clinical researchCreate presentations for dissemination of the results and other tasks related with the finalization of the clinical trialMedical monitoring of the trialsOversee a lab report review, CRF safety review, and potential endpoint reporting, for clinical projectsReview medical listings and create queriesProvide medical responses to potential questions from the investigators, ERCs and HAAttendance to the CRO ´s training, investigators meetings, blinded data review meeting, and other meetings related with their medical responsibility of the clinical trialReview and follow Scientific Advice conclusions for applicable projectsProvide support in interactions with regulatory authorities regarding clinical trial protocol, protocol amendments, briefing package, and clinical part of registration dossiersProvide support in regulatory agency inspections and internal audits of assigned projectsOrganise the drafting and revisions of posters and papers to disseminate the results from the clinical research activitiesActively contribute to reviewing and following Standard Operating Procedures and Working InstructionsQualifications Degree in MedicineExperience in Clinical Research in the Pharmaceutical IndustryWhat We Offer We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
