Regional Clinical Trial Management Associate
hace 2 semanas
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Only Applicants with a valid work permit will be considered - we do not provide sponsorship for this position
General Description:
Role will support the study team with Clinical Operations tasks, and/or assist in ensuring compliance including completeness and quality checks of the trial master file (TMF) Demonstrates basic clinical operations knowledge and strong organizational skills Implements best practices and shares lessons learned with team and other colleagues, as appropriate Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs The Junior Associate role in Clinical Operations is an entry level positionThis job description provides the broadest description of potential assigned activities. There will be specific roles and responsibilities assigned from this Job Description, according to project assignment(s). As such, responsibilities will include some of the following activities, but may not be limited to :
Clinical Operations support to study teams:
Support cross-functional clinical study teams from start-up through close-out:
Assists in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking) Preparation and documentation of internal and external meetings by preparing agendas and minutes Maintaining clinical operations tracking tools e.g.enrollmentCTMSlaboratory samplesmonitoring visitssite statussupport in HA and IRB/EC submissions; support study team with site start-up preparation, EC fee application and trackingdrug supplydata cleaningvendor trackingtrainingrisk managementstudy goalsinvestigator contracts and payments; support study team with site level payments and invoicesinvoice reconciliation and budget tracking Support reporting for Senior Management updates Clinicaltrials.gov and/or local registry posting and maintenance Site materials and equipment: support study team with distribution of site materials and equipment, document printing, shipment, and other administrative work Administrative: business and department office administration support if requiredTrial Master File (TMF)
Support Clinical Operation Managers (COMs) with the setup, maintenance and close out of TMF. Coordinate document collection from others as appropriate. Upload documents to eTMF or other applicable document repositories ensuring quality documents are uploaded. Support TMF completeness activities. Follow TMF Plans, applicable SOPs, ICH/GCP guidelines and regulatory requirements. Support actions ensuring the TMF is submission/inspection ready Develop successful cross-functional relationships with internal and external TMF stakeholders Oversee documentation flow within projected timelines and determine course of action needed to prevent and remediate delays and errors with TMF compilation Support COMs in monitoring and reporting on progress of the TMF to stakeholders Apply lessons learned and demonstrate continuous improvement of documentation management practices across study teams Perform other TMF related tasks as needed.Mentoring Responsibilities:
More senior members of the associate team may mentor junior associates Associates with experience in specific tasks may mentor other associates with less or no experience in these tasksEducation Required:
Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 2 years of experience in clinical operations (Senior Associate). Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 1 year of experience in clinical operations (Associate). Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* (Junior Associate). Entry level.*Exceptions may be made on case-by-case basis where candidates demonstrate appropriate skill set for a role in Clinical Operations and awareness of the role.
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications:
Ability to work independently and effectively handle multiple priorities in a fast-paced environment Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organizationTravel: up to15%
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity-
Regional Clinical Trial Management Associate
hace 2 semanas
Alcobendas, Madrid, España BeiGene A tiempo completo**Job Summary:** The Clinical Operations Associate will provide support to study teams with clinical operations tasks, ensuring compliance with ICH/GCP, local regulations, and SOPs. The successful candidate will have a strong understanding of clinical operations and be able to implement best practices and share lessons learned with the team. **Key...
-
Regional Clinical Trial Management Associate
hace 2 semanas
Alcobendas, España Beigene A tiempo completoBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.Only Applicants with a valid work permit will be...
-
Senior Clinical Research Associate
hace 4 semanas
Alcobendas, Madrid, España Parexel A tiempo completoAt Parexel, we believe in the power of shared values to drive success. Parexel is dedicated to enhancing global health by offering a comprehensive range of biopharmaceutical services that assist clients worldwide in translating scientific innovations into effective treatments. Our capabilities span clinical trials, regulatory affairs, consulting, and...
-
Site Contract Associate
hace 1 semana
Alcobendas, Madrid, España Parexel A tiempo completoAbout the RoleParexel is seeking a highly skilled Site Contract Associate to join our team in Spain. As a key member of our Clinical Research team, you will be responsible for negotiating and finalizing site contracts, ensuring compliance with regulatory requirements and company policies.Key ResponsibilitiesNegotiate and finalize site contracts, including...
-
Site Contract Associate
hace 1 semana
Alcobendas, Madrid, España Parexel A tiempo completoAbout the RoleParexel is seeking a highly skilled Site Contract Associate to join our team in Spain. As a key member of our Clinical Research team, you will be responsible for negotiating and finalizing site contracts, ensuring compliance with regulatory requirements and company policies.Key ResponsibilitiesNegotiate and finalize site contracts, including...
-
Clinical Research Associate Ii
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Clinical Monitoring Associate
hace 4 semanas
Alcobendas, Madrid, España Parexel A tiempo completoAt Parexel, we believe that aligning our values leads to limitless achievements. Key Responsibilities Ensure adherence to regulatory standards, ICH-GCP guidelines, and study protocols. Utilize judgment and expertise to assess site performance and staff capabilities, providing actionable recommendations; promptly communicate significant issues to...
-
Clinical Research Associate II
hace 5 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our...
-
Patient Data Specialist
hace 5 días
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoAbout the RoleWe are seeking a highly skilled Patient Data Specialist to join our team at Precision Medicine Group. As a key member of our clinical operations team, you will play a critical role in ensuring the accuracy and integrity of clinical trial data.Key ResponsibilitiesData Review and Quality Assurance: Conduct thorough reviews of clinical trial data...
-
Patient Data Specialist
hace 6 días
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoAbout the RoleWe are seeking a highly skilled Patient Data Specialist to join our team at Precision Medicine Group. As a key member of our clinical operations team, you will play a critical role in ensuring the accuracy and integrity of clinical trial data.Key ResponsibilitiesData Review and Quality Assurance: Conduct thorough reviews of clinical trial data...
-
Senior Clinical Research Monitor
hace 4 semanas
Alcobendas, Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Parexel is dedicated to enhancing global health. We achieve this by offering a comprehensive range of biopharmaceutical services that assist clients worldwide in transforming scientific breakthroughs into innovative therapies. Our capabilities in clinical trials, regulatory affairs,...
-
Senior Clinical Research Monitor
hace 4 semanas
Alcobendas, Madrid, España Parexel A tiempo completoAt Parexel, we believe in the power of collaboration to achieve remarkable outcomes. Parexel is dedicated to enhancing global health by offering a comprehensive range of biopharmaceutical services that assist clients worldwide in converting scientific innovations into effective treatments. Our expertise spans clinical trials, regulatory affairs,...
-
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoJob SummaryThe Senior Clinical Data Manager/Principal Clinical Data Manager will oversee all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. This role is responsible for ensuring compliance with Standard Operating Procedures, regulatory directives, and study-specific plans.Key...
-
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoJob SummaryThe Senior Clinical Data Manager/Principal Clinical Data Manager will oversee all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. This role is responsible for ensuring compliance with Standard Operating Procedures, regulatory directives, and study-specific plans.Key...
-
Site Contract Associate
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.PAREXEL is in the process of recruiting a Site Contract Associate to work home-based in Spain.This role focuses on legal contracts within the fascinating industry of international Clinical Research, and will support Portugal's Business needs so being fluent in Portuguese is a must.The Site...
-
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoJob SummaryThe Senior Clinical Data Manager/Principal Clinical Data Manager is a key member of our team at Precision Medicine Group, responsible for overseeing all aspects of clinical trial data management. This role involves managing the data management process from study start-up to post-database lock, ensuring compliance with regulatory directives and...
-
Alcobendas, Madrid, España Precision Medicine Group A tiempo completoJob SummaryThe Senior Clinical Data Manager/Principal Clinical Data Manager is a key member of our team at Precision Medicine Group, responsible for overseeing all aspects of clinical trial data management. This role involves managing the data management process from study start-up to post-database lock, ensuring compliance with regulatory directives and...
-
Clinical Research Associate
hace 2 días
Alcobendas, Madrid, España Parexel A tiempo completo{"title": "Site Care Partner", "description": "Transforming Scientific Discoveries into New TreatmentsParexel FSP is a leading Contract Research Organization (CRO) that conducts vital clinical studies for sponsors, including the world's leading biotech's and top 50 pharmaceutical companies. We are seeking a highly skilled Site Care Partner to join our team...
-
Clinical Research Associate
hace 2 días
Alcobendas, Madrid, España Parexel A tiempo completo{"title": "Site Care Partner", "description": "Transforming Scientific Discoveries into New TreatmentsParexel FSP is a leading Contract Research Organization (CRO) that conducts vital clinical studies for sponsors, including the world's leading biotech's and top 50 pharmaceutical companies. We are seeking a highly skilled Site Care Partner to join our team...
-
Clinical Research Lead
hace 4 meses
Alcobendas, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...