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(Trr747) - Associate Clinical Trial Regulatory Manager
hace 2 meses
.Job Title: Associate Clinical Trial Regulatory Manager (ROW)Job Location: Madrid, Spain (Home-based, any location in Spain considered)Job Overview: The Associate Clinical Trials Regulatory Manager (CTRM) will oversee the maintenance phase of a clinical study following initial site activation through study closure. The Associate Clinical Trial Regulatory Manager directly supports the study Project Manager by collaborating with Clinical Trial Manager (CTM), Clinical Trial Associate (CTA), and Country Specialists.Job Duties and Responsibilities: Prepare timelines and oversee the execution of the Clinical Trial Application Amendments (CTAA) and clearly communicate with the internal and Sponsor project teams.May support initial start-up activities (prior Site Initiation Visits) for a limited number of sites.Responsible for tracking relevant timelines and activities; and reporting on the progress to the study team and the Sponsor per agreed frequency.Manage Country Specialists (including contracted individuals) appointed to the project ensuring their project-related training is completed prior to performing any project activities as detailed by relevant SOPs.Prepare the CORE CTAA package; including the review ofthe relevant documents (protocol, IB, IMPD, and any patient-facing documents as applicable) and obtain acceptance from the project manager and approval from the client for the document package.Review and approval of CA/EC Country amendment submission dossier; and may perform CountryAmendment submissions to CA/EC including queries management.May draft cover letters, support review of ICFs, review translations, provide summarized translations for GNA/deficiencies, and communicate with the CEC and/or CA in local language, as necessary.Inform project team about amendment approvals for immediate implementation.Accountable for Annual Progress Report submission, End of Trial notification, Clinical Study Report submission.May be responsible for translation of requested SSU documents and communication link with translation vendor.Capable to independently operate in electronic databases and systems such as Trial Master Trials, CTMS, and time recording following relevant training.May act as a regional Start-Up Lead or Country Expert depending on experience and current Clinipace needs.Capable to provide regional or local country procedural and legal advice/guidance to internal and Sponsor project teams.Demonstrates flexibility, patience, strong attention to detail, and excellent time management.Supervisory Responsibilities: No supervisory responsibilities.Job Requirements: Education: Bachelor's graduate with a healthcare or life science degree or equivalent experience.Experience: Minimum of 4 years of experience in the Clinical Research industry, country start-up specialist experience in a Clinical Research Organization (CRO) setting preferred. Experience with clinical study startup with hands-on experience of regulatory and site activation preferred
