Cdc Trial Manager

hace 2 meses


Madrid, España Reconocida Empresa A tiempo completo

.CDC Trial ManagerCategory : Clinical DevelopmentLocation : Madrid, Comunidad de Madrid, ESAre you passionate about Trial Management and would like to be part of the patient's life change? Do you want to be part of our Clinical Development Centre (CDC) team integrated by Spain and Portugal?We are currently recruiting 2 Clinical Trial Managers for our Cardiovascular and RareD teams. Our office is in Madrid, but the position could be based anywhere in Spain.The Position As a Clinical Trial Manager working in the Cardiovascular Disease (CVD) or Rare Diseases (RareD) team, you will use your project management skills to drive clinical trials in the CDC forward, ensuring they are in accordance with the protocol, company policies, Standard Operating Procedures (SOPs), countries' legislation, and ICH GCP requirements.You will be responsible for all aspects of the clinical trials within the CDC project team of CRAs and CTAs, including strategy, country budget, recruitment, retention, risk analysis and management, database lock (DBL), and archiving.Your responsibilities will include: Project planning, management, and execution of assigned clinical trials in the CDC and adjacent affiliates in accordance with applicable regulatory requirements, NN Protocols, and SOPs.Coordinating the CDC trial teams at a project level within the 2 countries.Leading the project team, taking accountability for the trial budget, ensuring successful start-up clinical activities, setting project-specific strategies, and providing direction to ensure successful project delivery.Leading the planning, execution, and communication between relevant roles, such as CDC, Clinical Trial Assistants, and Clinical Research Associates (CRA), as well as CRA coaching.Ensuring effective communication of all trial-related issues between the headquarters, CDC, other affiliates, and other internal/external stakeholders.Acting as project manager for the trial management activities in the CDC from site selection to post-clinical trial activities.Representing CDC countries in study meetings as relevant: Country Calls, Monitor and Investigator meetings, Study Result meetings.Proactive risk identification and mitigation plans at the CDC level and adjacent affiliates.We are looking for a passionate and proactive solution-oriented professional able to coordinate tasks, identify potential risks as well as mitigations, and effectively communicate between the Trial Squads, the Monitors (CRAs), and the Heads of Clinical/Clinical Research Managers to facilitate progress and global coordination of the clinical trial programme.Qualifications Minimum Bachelor's degree level in Life Sciences or equivalent.Strong experience in Clinical Research, including at least 2 years in a Trial Management role. Experience with international clinical trials is desired for this position.Strategic and analytical mindset. Critical thinking, risk analysis, project management


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