Information about: Beca Medical Department / Site Management & Monitoring in Madrid

Company looking for Beca Medical Department / Site Management & Monitoring

Madrid, Spain

Offer description

•Completion of required trainings within the agreed timelines.  •Familiarization with the structure of the Clinical Study Protocol and how to manage them.  •Process of the development of informed consent forms - global and local process until its approval and implementation •Process of identification of potential centres and how to conduct selection visits. •Monitoring plan and how to ensure it is followed. What are SDV and SDR? •Study start-up activities and regulatory maintenance management. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. •Accompanied Site Initiation visits (previous preparation and subsequent follow-up letter and activities). •Accompanied Site monitoring visits (previous preparation and subsequent follow-up letter and activities) •Accompanied Remote visits (previous preparation and subsequent follow-up letter and activities •Accompanied Site closure visits, (previous preparation and subsequent close out activities). •Remote data checks- what to review and how to document it •Site training and support management, including Risk Based Quality Management (RbQM) principles. •Participation in meetings of Researchers (provided they take place in Madrid) and assist in preparation for international meetings. •Query resolution process: how to do it in a timely manner and provide support if required. •Serious Adverse Events management and their notification. Follow up activities. •Medication management throughout the clinical trial cycle (including the final drug accountability). •Attendance at Local and Global meetings and/or tele-conferences   and learn how to be prepared for them •Study management tools: CTMS, RAVE, IVRS, SQRA tool, study dashboards, ect. •Study document management: how to ensure that sites are always inspection ready •Study files: eTMF and ISF- maintenance, update and documentation tracking. Inspection readiness •Study administrative support if needed: scanning, copying and filing. •Study Protocol Amendment management until its implementation. •Safety letter management •Protocol deviation handling and reporting: CAPAS •Applicable legislation related to clinical trials. 

Applicant description

• Good knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP and knowledge of relevant local regulations. •Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. •Basic understanding of the drug development process. •Good understanding of Clinical Study Management including monitoring, study drug handling and data management. •Excellent attention to details. •Good written and verbal communication skills •Good collaboration and interpersonal skills. •Good analytical and problem-solving skills.