Clinical Trial Specialist

Key responsibilities of quality assurance auditors include ensuring compliance and quality at clinical trial sites.Auditors conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP, and regulatory requirements.The role involves identifying and reporting audit findings; recommending corrective actions and supporting site staff...

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...

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...

**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...

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...

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...

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 OpportunityWe are seeking highly skilled Neuroradiologists to collaborate as Subject Matter Experts (SMEs) on advanced robotic surgery and medical AI projects. This role offers complete flexibility to fit alongside existing clinical commitments.Perform manual data annotation across various imaging modalities.Train and mentor specialist annotation...

Medical Safety Specialist Role OverviewThe primary objective of this position is to provide expert medical input in the evaluation of safety data from various sources, as part of an integrated pharmacovigilance process.Conduct thorough medical reviews and clarifications of trial-related adverse events and post-marketing adverse drug reactions.Develop, edit,...