Empleos actuales relacionados con Clinical Trial Manager - Madrid - Bristol-Myers Squibb
-
Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm
hace 2 semanas
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** Experience in the management of global/multi-country studies and different types of vendors is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...
-
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based Spain** Experience in the management of global/multi-country studies is required Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...
-
Clinical Trial Manager
hace 4 días
Madrid, España Precision for Medicine A tiempo completoWe have current opportunity for an experienced Clinical Trial Manager in Europe! Join our growing team. Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...
-
Clinical Trial Manager
hace 4 días
Madrid, España Bristol-Myers Squibb A tiempo completo**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Sr Clinical Trial Manager, Oncology
hace 1 semana
Madrid, España Boston Scientific Corporation A tiempo completoAt Boston Scientific, we’re committed to transforming lives through less invasive products and technologies that diagnose and treat a wide range of medical conditions. Our innovations span key therapeutic areas and are expanding into new geographies and high-growth adjacent markets. Our **Interventional Oncology and Embolization (IO&E)** portfolio...
-
Junior Clinical Trial Manager
hace 5 días
Madrid, España Parexel A tiempo completoOverview Parexel FSP is recruiting for a Junior Clinical Trial Manager based in Spain. Home based role. Dedicated to a single sponsor. You will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important...
-
Clinical Trial Manager
hace 1 semana
Madrid, España Icon plc A tiempo completoClinical Trial Manager - Sponsor Dedicated (global) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Trial...
-
Clinical Trial Project Coordinator
hace 5 días
Madrid, España Medpace A tiempo completoA clinical research organisation based in Madrid is seeking a Project Coordinator to oversee clinical trial management. Responsibilities include collaborating with the Project Clinical Trial Manager, managing study supply logistics, and maintaining project timelines. Ideal candidates will have a Master's in Life Sciences, clinical trial experience, and...
-
Madrid, España Medpace A tiempo completoA leading clinical research organization is seeking a Clinical Trial Manager for their Madrid office, focusing on CNS/Ophthalmology. Responsibilities include managing day-to-day project operations and providing oversight to the project team. Candidates should possess a Bachelor's degree in a related field and 2+ years of Clinical Trial Management experience....
-
Remote Junior Clinical Trial Manager – Spain
hace 1 semana
Madrid, España Parexel A tiempo completoA global contract research organization is seeking a Junior Clinical Trial Manager based in Madrid, Spain. In this role, you will be responsible for managing clinical trials from initiation to closeout, ensuring compliance with GCPs and regulatory standards. The position requires strong experience in clinical trial documentation, problem-solving, and...
Clinical Trial Manager
hace 12 horas
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
**Position Summary**
The Clinical Trial Manager (CTM) is accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.
**Key Responsibilities**
- Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.
- Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
- Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders.
- Implement country and site level patient recruitment strategy and risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s. Assessment and set up the of vendors during study start up period (locally)
- Investigator Meeting participation and preparation.
- Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF.
- Validation of study related materials (i.e. protocol, ICF, patient material).
- Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.
- May support preparation of materials for Site Initiation Visits.
- Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
- Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.
- Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
- Coordination of database locks and query follow up. Ensures timelines are met.
- Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities.
- Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
- Coordinate study team meetings locally.
- Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable).
- Collaborates with the local study team to support the management of site relationships (may include CRO related issues).
- May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).
- May perform site closure activities, including post-close out.
- May act as point of contact for Sites.
- As required per country requirements, perform or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
- Perform submission to Ethics Committees and governance offices, where applicable, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams, as applicable.
- May support the collection and distribution of documents to and from sites.
- Support the approval for closure of funds/POs.
- May update national registries where applicable.
- Serves as a coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal.
**Qualifications & Experience Degree/Certification/Licensure**:
- Bachelor's or master's degree required. Field of study within life sciences or equivalent Experience:
- Minimum of 4 years' industry relate
