Clinical Data Compliance Specialist
vor 3 Wochen
Key Responsibilities
- Coordinate operational compliance activities on one or more studies to ensure successful delivery of the studies.
- Ensure accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF's, queries, and patient recruitment statuses; reports out the flow of data.
- Maintain ISF and study trackers as delegated.
- Follow the QC process and checks that ICF's are correctly completed.
- Ensure that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
- QC's all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
- Assist with archiving procedures if required.
- Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
- Identify quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses.
- Prepare and collate regulatory documents for submission.
- Interpret and adhere to company SOP and COP, and assists with input during the review process.
- Adhere to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
- Assist with drafting compliance reports.
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitAbout the RoleAt Worldwide Clinical Trials, we are seeking a highly skilled Senior Clinical Research Associate to join our team. As a Senior Clinical Research Associate, you will be responsible for managing clinical trials from start to finish, ensuring that all aspects of the trial are conducted in accordance with regulatory requirements and Good Clinical...
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Clinical Site Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitTransforming Healthcare Through InnovationParexel is seeking a Clinical Site Monitor I or II to join our team. As a home-based Clinical Site Monitor, you will play a critical role in ensuring data integrity and quality, and ensuring compliance with ICH GCP and local regulations at the site level.The successful candidate will be responsible for monitoring...
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Data Compliance Specialist
vor 1 Monat
Berlin, Berlin, Deutschland Thermo Fisher Scientific VollzeitThermo Fisher Scientific is seeking a skilled Data Compliance Coordinator to oversee data and quality control in the clinical trial process.Key Responsibilities:Coordinate operational compliance activities on one or more studies to ensure successful delivery of the studies.Ensure accurate and timely entry of all data in the CRF from the source notes, and...
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Data Compliance Specialist
Vor 2 Tagen
Berlin, Berlin, Deutschland Thermo Fisher Scientific VollzeitUnlock a Rewarding Career at Thermo Fisher ScientificSalary: €55,000 - €65,000 per annumAbout the RoleWe are seeking a highly organized and detail-oriented Data Compliance Coordinator to join our clinical site in Berlin, Germany.In this exciting opportunity, you will be responsible for ensuring the accuracy and timeliness of data entry, maintaining...
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Data Compliance Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Thermo Fisher Scientific VollzeitAt Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner and safer.As a Data Compliance Coordinator, you will play a critical role in ensuring the accuracy and integrity of clinical trial data.Your key responsibilities will include:Coordinating operational compliance activities on one or more studies to...
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Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Worldwide Clinical Trials. As a Clinical Research Associate, you will be responsible for conducting remote psychiatric patient interviews for clinical trials, preparing scoring rationale for interviews, and entering data following each interview.Key...
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Senior Clinical Development Manager
vor 4 Wochen
Berlin, Berlin, Deutschland Pharmiweb VollzeitJob Title: VP Clinical DevelopmentAt Pharmiweb, we are seeking a highly skilled and experienced VP Clinical Development to lead our clinical development projects in Oncology. As a key member of our team, you will be responsible for the planning, execution, and delivery of clinical trials, ensuring compliance with regulatory requirements and industry...
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Senior Clinical Research Associate
vor 3 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitGlobal Partnership in Clinical Trials:At Worldwide Clinical Trials, we work in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.We have a dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, which enables us to...
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Clinical Research Associate
vor 1 Monat
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential as a Clinical Research AssociateParexel is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for conducting clinical trials, collecting and analyzing data, and ensuring compliance with regulatory requirements.Key Responsibilities:Conduct...
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Data Quality Specialist
vor 1 Woche
Berlin, Berlin, Deutschland BASF Services Europe GmbH VollzeitAbout UsBASF Services Europe GmbH, a leading provider of services for the BASF Group throughout Europe, is seeking a Data Quality Specialist to join its team. In this role, you will be responsible for improving data processes and structures within the Agricultural Solutions division.The ideal candidate will have a strong background in data analysis, with...
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Clinical R&D Manager for Medical Devices
vor 3 Wochen
Berlin, Berlin, Deutschland LINDERA GmbH VollzeitAbout the RoleWe are seeking a highly skilled Clinical R&D Manager for Medical Devices to lead our research and development efforts in creating innovative healthcare solutions.The ideal candidate will have extensive experience in clinical research and development, as well as a strong understanding of medical devices and their regulations.Lead research and...
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Data Quality Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Wolt VollzeitJob OverviewWe are seeking a highly skilled Data Quality Specialist to join our team at Wolt. As a Data Quality Specialist, you will be responsible for ensuring the accuracy and compliance of product information on our platform.Key ResponsibilitiesDrive data compliance topics for product information on Wolt's platform, ensuring high standards across our...
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Clinical Operations Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland Siemens Healthineers AG VollzeitRole OverviewWe are seeking a skilled Clinical Operations Specialist to join our team in Clinical Operational Consulting.About the RoleThis role involves supporting the expansion of our consulting organization in line with our business plan. You will lead projects within healthcare facilities, collaborating with customers, developing efficiency-focused...
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Clinical Sales Specialist
vor 6 Stunden
Berlin, Berlin, Deutschland ottobock VollzeitOverviewOttobock is a leading provider of advanced prosthetic and orthotic solutions, dedicated to helping people maintain and regain their freedom of movement. We are seeking a highly skilled Clinical Sales Specialist to join our team in promoting Exopulse, a cutting-edge solution for therapy and pain management.
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Clinical Microbiology Application Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Danaher VollzeitUnlock the Power of Clinical MicrobiologyAt Danaher, we're committed to advancing healthcare through innovative diagnostics solutions. As an Application Specialist Clinical Microbiology, you'll play a vital role in ensuring the successful implementation and utilization of our microbiology diagnostics instruments and solutions.About the RoleThis position is...
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Clinical R&D Director for Medical Devices Innovation
vor 4 Wochen
Berlin, Berlin, Deutschland LINDERA GmbH VollzeitWe are seeking a highly skilled Clinical R&D Manager to lead our medical device research and development efforts. As a key member of our team, you will be responsible for driving the continuous improvement of our AI-based fall prevention solutions.About LINDERA GmbH:LINDERA GmbH is a pioneering company in the field of digital health innovation, specializing...
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Data Protection Specialist
vor 1 Monat
Berlin, Berlin, Deutschland DataGuard VollzeitAt DataGuard, we are seeking a highly motivated and detail-oriented Data Protection Specialist to join our interdisciplinary privacy team. The ideal candidate will have a strong understanding of data protection law and be able to work independently with our corporate clients in various industries.ResponsibilitiesSupport our team in implementing data...
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Compliance Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland BTB Blockheizkraftwerks-, Träger- und Betreibergesellschaft mbH Berlin Vollzeit**Über die Rolle**Wir suchen einen Compliance Specialist für unser Team, der sich auf die Einführung und Weiterentwicklung interner Compliance-Regelungen spezialisiert hat. Als Koordinator für Compliance und Risikomanagement ist er verantwortlich für die Sicherstellung der Einhaltung gesetzlicher und unternehmensinterner...
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Payroll Compliance Documentation Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Remote VollzeitAbout the RoleWe are seeking a highly skilled Payroll Compliance Documentation Specialist to join our Payroll team at Remote. As a key member of our team, you will be responsible for analyzing documentation needs, evaluating the effectiveness of current documentation, and providing proactive recommendations to ensure a high-performance culture.Key...
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Legal Compliance Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Arendt & Medernach VollzeitArendt & Medernach is a leading business law firm in Luxembourg, with a strong international presence and a team of over 800 professionals. Our firm provides end-to-end specialist advice to clients, covering all legal, regulatory, taxation, and advisory aspects of doing business in Luxembourg.We are seeking a highly skilled Legal Compliance Analyst to join...