Clinical Data Specialist

1 day ago

alwar, India beBeeClinical Full time

Job Title: Clinical Data SpecialistWe are seeking a highly skilled and experienced Clinical Data Specialist to join our team. The ideal candidate will have extensive knowledge of electronic data capture (EDC) systems, data management, and clinical trial operations.About the Role:This is an exciting opportunity for a seasoned professional to leverage their expertise in EDC systems, data management, and clinical trial operations to drive quality and efficiency in our organization.Create electronic case report form (eCRF) specifications, design, develop, and validate clinical trial setup processes to ensure data accuracy and integrity.Design and implement edit check specifications and set up edit checks at trial level to prevent data errors and inconsistencies.Develop and implement user acceptance testing (UAT) scripts to test the setup of the clinical study and ensure it meets requirements.Set up different instances of study URL (e.g., UAT, production, testing etc.) for seamless data exchange and collaboration.Configure user accounts for study teams to manage access and permissions.Manage blinded and unblinded study configurations to maintain data confidentiality and integrity.Serve as a subject matter expert (SME) for all EDC database-related activities to provide guidance and support.Collaborate with technology vendors to establish technology standards and governance models to ensure quality and consistency.Oversee the system delivery life cycle in collaboration with partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations to ensure timely and successful delivery.Partner with leaders to resolve issues affecting the delivery of clinical trials and ensure adoption of new capabilities and business processes.Key Responsibilities:eCRF specification, design, development, and validationEdit check specification and implementationUser acceptance testing (UAT) script developmentStudy URL setup and configurationUser account managementBlinded and unblinded study configuration managementSubject matter expert (SME) for EDC database activitiesIntegration of EDC ecosystem modulesTechnology standard and governance model establishmentSystem delivery life cycle oversightIssue resolution and process improvementRequirements:Strong background in electronic data capture (EDC) systems and data managementExtensive experience in clinical trial operations and managementExcellent technical and analytical skillsAbility to work effectively in a team environmentStrong communication and interpersonal skillsHighly organized and detail-oriented with ability to prioritize tasksBachelor's degree in computer science, information technology, or related fieldMinimum 5 years of experience in clinical data management and EDC systemsWhat We Offer:Competitive salary and benefits packageOpportunities for career growth and professional developmentCollaborative and dynamic work environmentRecognition and rewards for outstanding performance

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