Clinical Affairs Program Manager
hace 4 días
At Chronos Consulting, we are seeking a highly skilled Clinical Affairs Program Manager to join our team. As a key member of our global clinical affairs team, you will be responsible for developing strategies for the successful execution of clinical trials that demonstrate medical product safety and efficacy.
Key Responsibilities:
- Collaborate with company stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, and other research initiatives.
- Oversee the design of clinical trials, including protocol development, clinical trial discussions with regulatory authorities, and development of timelines and budgets.
- Manage the process of screening, qualifying, selecting, and contracting with investigators, sites, and vendors required for the conduct of clinical trials.
- Direct and manage necessary clinical trial approvals from Institutional Review Boards (IRBs) and Ethics Committees (ECs), and ensure studies are on track for site initiation, patient recruitment, and enrollment.
- Develop budgets for all clinical projects and adhere to company financial goals.
- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Develop, maintain, and expand collaborations with company stakeholders, clinical investigators, and researchers to optimize clinical development programs.
- Participate in the development of Standard Operating Procedures (SOPs) and work instructions to ensure internal files and clinical study files conform to Good Clinical Practice regulations and standards.
- Ensure adherence to protocols and compliance with regulatory guidelines, including FDA, ICH, ISO, and GCP.
- Identify clinical training needs and develop training materials for in-house and clinical site use.
Requirements:
- BS, BA, BSN, or RN or higher degree in the Life Sciences or related disciplines.
- Minimum 3+ years in clinical management position in the biopharmaceutical or device industry, Clinical Research Organization, or related field.
- Additional 4+ years direct experience in clinical trial management.
- Solid track record in successfully executing Phase I-III clinical trials.
- Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines.
- Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting.
- Knowledge of electronic data capture systems and web-based clinical trial management tools.
- Excellent interpersonal, written/verbal communication, computer, and organizational skills, strong program management and financial skills.
- Excellent command of the English language; both written and verbal.
- Collaborative team player with strong abilities to operate independently.
- Willing and able to travel domestically and internationally, as required (up to 40%).
-
Regulatory Affairs Director
hace 3 días
Madrid, Madrid, España Worldwide Clinical Trials, LLC A tiempo completo{"title": "Regulatory Affairs Manager", "content": "Regulatory Affairs ManagerAt Worldwide Clinical Trials, LLC, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Review and manage...
-
Regulatory Affairs Director
hace 3 días
Madrid, Madrid, España Worldwide Clinical Trials, LLC A tiempo completo{"title": "Regulatory Affairs Manager", "content": "Regulatory Affairs ManagerAt Worldwide Clinical Trials, LLC, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Review and manage...
-
Clinical Project Manager
hace 7 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoJob SummarySyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We are seeking a highly skilled Clinical Project Manager - Sponsor Dedicated to join our team.About the RoleAs a Clinical Project Manager - Sponsor Dedicated, you will be responsible for managing projects as a project manager...
-
Clinical Project Manager
hace 6 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoJob SummarySyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We are seeking a highly skilled Clinical Project Manager - Sponsor Dedicated to join our team.About the RoleAs a Clinical Project Manager - Sponsor Dedicated, you will be responsible for managing projects as a project manager...
-
Medical Affairs Manager
hace 5 días
Madrid Centro, Madrid, España Bausch & Lomb A tiempo completoJob SummaryBausch & Lomb is seeking a highly skilled Medical Affairs Manager to provide support to the Clinical Evaluation Group for ongoing assessment of the safety and performance clinical data of the Bausch+Lomb Surgical Medical Devices Portfolio.Key ResponsibilitiesClinical Evaluation Reports: Create and update Clinical Evaluation Reports to ensure...
-
Medical Affairs Manager
hace 4 días
Madrid Centro, Madrid, España Bausch & Lomb A tiempo completoJob SummaryBausch & Lomb is seeking a highly skilled Medical Affairs Manager to provide support to the Clinical Evaluation Group for ongoing assessment of the safety and performance clinical data of the Bausch+Lomb Surgical Medical Devices Portfolio.Key ResponsibilitiesClinical Evaluation Reports: Create and update Clinical Evaluation Reports to ensure...
-
Senior Manager, Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Worldwide Clinical Trials A tiempo completoAbout UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.Our company's scientific heritage is anchored in our dedicated therapeutic focus on cardiovascular, metabolic,...
-
Senior Manager, Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Worldwide Clinical Trials A tiempo completoAbout UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.Our company's scientific heritage is anchored in our dedicated therapeutic focus on cardiovascular, metabolic,...
-
Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable...
-
Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our services are conducted in accordance with Innovaderm's standard operating procedures, applicable...
-
Senior Manager, Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Worldwide Clinical Trials, Llc A tiempo completoAbout the Role**Job Summary**We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to join our team at Worldwide Clinical Trials, LLC. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and providing expert advice on regulatory matters.Key...
-
Senior Manager, Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Worldwide Clinical Trials, Llc A tiempo completoAbout the Role**Job Summary**We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to join our team at Worldwide Clinical Trials, LLC. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and providing expert advice on regulatory matters.Key...
-
Clinical Science Manager
hace 3 días
Madrid Centro, Madrid, España Qiagen Gruppe A tiempo completoUnlock Your Potential at QIAGENAt QIAGEN, we're driven by a passion for making a real difference in science and healthcare. As a Clinical Science Manager, you'll be part of a dynamic team that's shaping the future of in vitro diagnostics. Our company is built on a culture of innovation, collaboration, and excellence, and we're looking for talented...
-
Clinical Science Manager
hace 3 días
Madrid Centro, Madrid, España Qiagen Gruppe A tiempo completoUnlock Your Potential at QIAGENAt QIAGEN, we're driven by a passion for making a real difference in science and healthcare. As a Clinical Science Manager, you'll be part of a dynamic team that's shaping the future of in vitro diagnostics. Our company is built on a culture of innovation, collaboration, and excellence, and we're looking for talented...
-
Medical Affairs Manager
hace 6 horas
Madrid Centro, Madrid, España Bausch & Lomb GmbH A tiempo completo{"h1": "Medical Affairs Manager", "p": "At Bausch & Lomb GmbH, we are seeking a highly skilled Medical Affairs Manager to join our Clinical Evaluation Group. As a key member of our team, you will provide support for the ongoing assessment of the safety and performance of our Bausch+Lomb Surgical Medical Devices Portfolio. Your expertise will be instrumental...
-
Medical Affairs Manager
hace 9 horas
Madrid Centro, Madrid, España Bausch & Lomb GmbH A tiempo completo{"h1": "Medical Affairs Manager", "p": "At Bausch & Lomb GmbH, we are seeking a highly skilled Medical Affairs Manager to join our Clinical Evaluation Group. As a key member of our team, you will provide support for the ongoing assessment of the safety and performance of our Bausch+Lomb Surgical Medical Devices Portfolio. Your expertise will be instrumental...
-
Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our clinical trials are conducted in accordance with applicable regulations and guidelines.Key...
-
Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs ManagerJob Summary:Innovaderm Research is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our clinical trials are conducted in accordance with applicable regulations and guidelines.Key...
-
Clinical Trial Supplies Manager
hace 6 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo**Job Summary**Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we...
-
Clinical Trial Supplies Manager
hace 6 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo**Job Summary**Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we...