Clinical Study Coordinator
hace 2 semanas
In a nutshell 📌Position: Clinical Study CoordinatorLocation: Madrid, HibridExperience: 4+ years in international clinical trial coordinationWant to know more? 👇mAbxience is a global biopharmaceutical company committed to innovation and excellence in the development and manufacturing of biotechnological medicines. We operate with a strong focus on quality, regulatory compliance, and scientific rigor to improve patient outcomes worldwide.What are we looking for? 🔎Oversee and ensure the proper execution and follow-up of clinical trials, managing CROs and vendors to meet timelines, quality standards, and regulatory requirements.Design and manage clinical trial plans, identifying risks and implementing corrective actions.Coordinate site and investigator selection, budget management, and vendor contracts.Ensure compliance with GCP, FDA, EMA, ICH guidelines, and internal procedures.Manage regulatory documentation and submissions, maintaining audit readiness.Supervise clinical trial monitoring, investigational product handling, and patient recruitment strategies.Collaborate with pharmacovigilance teams to ensure timely reporting and management of safety events.Support quality management through monitoring reports, deviation handling, and protocol amendments.Maintain effective communication with internal teams, CROs, investigators, and regulatory authorities.What do you need? 🤓Degree in Health Sciences; Master’s degree is a plus.Fluent in English and Spanish; additional languages are an asset.Minimum 4 years’ experience coordinating international clinical trials and managing CROs.Deep knowledge of international clinical trial regulations (ICH-GCP, FDA, EMA).Experience in oncology is a strong plusStrong organizational, communication, and interpersonal skills.Ability to work under pressure and prioritize tasks effectively.Willingness to travel up to 10%.Our benefits 👏⏰ Flexible start time from Monday to Friday (full-time).📜 Permanent contract.💸 Attractive salary package.🥼 Life and accident insurance.🍽️ Ticket restaurant💸 Benefits and Savings Club.📈 Development plans, internal mobility policy.⭐ Many moreWhat will the Selection process be like? 🕵️➡️ Stay tuned to your phone and email The first thing we will likely do is contact you through one of the two channels.➡️ Prepare well We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.➡️ Wait for the result We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.🔷 Do you think this offer is not for you? 🔷Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting#mAbxience #ClinicalStudyCoordinator #BiotechCareersCOMMITMENT TO EQUAL OPPORTUNITIESmAbxience is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees regardless of gender, ethnicity, religion, sexual orientation, disability, or any other characteristic.
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