Study Start-Up Analyst

Clinical OperationsBuenos Aires, Argentina Be the catalyst that brings clinical trials to life. Navigate regulatory complexities, partner with health authorities and ethics committees, and ensure studies launch successfully. Your new roleAs a Study Start-Up Analyst, you'll own the end-to-end execution of study start-up and submission activities for assigned clinical trials. You'll be the regulatory expert who ensures everything is in place for trials to launch on time and in full compliance. Your responsibilities will include:Leading the preparation, review, and submission of Health Authority (HA) and Ethics Committee (EC) dossiers, ensuring compliance with ICH GCP regulations and local requirementsObtaining regulatory documentation and requirements to initiate studies—navigating ethics committee requirements, submitting to authorities, and strategically managing objectionsDriving internal approvals for labels and documents, including the customization, translation, and validation of I...