Clinical Trial Compliance Specialist

Company DescriptionConcept Clinical Service is a Research Management Organization dedicated to supporting clinical trials in the pharmaceutical, biotechnology, and medical device industries. Our services ensure stringent adherence to protocols, extensive documentation, quality data collection and reporting, and compliance with ICH-GCP and other regulatory...

**Responsibilities**: - Maintain and organize Trial Master File (TMF) and essential documents. - Track study progress, including patient enrollment and site communications. - Assist with the preparation and submission of regulatory documents. - Schedule meetings, take minutes, and support trial team coordination. - Ensure compliance with Good Clinical...

Quality Assurance Auditor Role OverviewAs a seasoned Clinical Site Auditor, you will play a pivotal role in ensuring clinical trial sites adhere to quality and compliance standards. This position requires a deep understanding of GCP, GLP, and regulatory requirements, as well as excellent communication and analytical skills.Key Responsibilities:• Conduct...

About the Role As a Clinical Specialist, you will play a vital role in maintaining the accuracy and consistency of clinical trial assessments. Your responsibilities include reviewing rating scales, evaluating assessment quality, and providing real-time feedback to raters. You will also participate in training and calibration sessions, conduct mock...

Expert Veeva EDC Programmer Job SummaryThe ideal candidate will have expertise in creating and validating clinical trial setup processes. Key responsibilities include creating eCRF specifications, implementing UAT scripts, setting up study URLs, configuring user accounts, and managing blinded and unblinded study configurations.

Role OverviewJob DescriptionAs a Data Scientist in our organization, you will be responsible for developing and maintaining ADaM datasets, TLFs, and other analytical outputs for clinical trials. Your primary focus will be on ensuring accuracy, consistency, and regulatory compliance in all programming deliverables.Develop ADaM datasets, TLFs, and other...

Medical Writer – Contract PositionAbout the Role:We are seeking a detail-oriented Medical Writer to contribute to regulatory and scientific documentation within the medical device sector.This is an exciting opportunity to work in a collaborative, cross-functional environment and be part of our dynamic scientific operations team.Key Responsibilities:•...

Job DescriptionLead Clinical ProgrammerThis role involves leading one or more Phase I-IV studies programming activities according to project strategies.The successful candidate will work independently, implementing and executing programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad...

We are seeking an expert in Healthcare Data Science to leverage and augment existing models generating insights supporting clinical studies and oncology research.Utilize and augment foundation models for healthcare-specific datasets.Drive data analysis and insight generation to support oncology-focused clinical trials.Collaborate with computational...

Job OverviewThe role of a Regulatory Compliance Specialist involves ensuring that our organization adheres to all relevant laws and regulations, utilizing the Enablon solution for this purpose.This specialist will be responsible for streamlining incident reporting, root cause analysis, audits, and inspections, thereby enhancing operational efficiency and...