Clinical Trials Technical Director
3 days ago
Senior Technical LeadThe role of a Senior Technical Lead involves providing strategic direction and technical expertise to ensure the successful delivery of clinical trials projects.Develop, validate and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs in compliance with CDISC standards and regulatory guidelines.Perform end-to-end statistical programming activities across all phases of Oncology clinical trials, collaborating with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.Support integrated analysis activities for ISS and/or ISE as part of regulatory submissions, ensuring that safety and efficacy analyses are conducted and presented effectively.Develop edit checks, data review listings, and derive specifications aligned with study requirements, leveraging strong problem-solving, analytical and documentation skills.Prepare programming specifications, data mapping documents, and validation checks, working closely with stakeholders to meet their needs.Requirements:Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline.7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred), with a strong working knowledge of ISS or ISE programming submissions.Expertise in creating safety and efficacy analysis outputs and submission packages, including edit checks development and dataset specifications.Strong analytical and documentation skills, with ability to work independently and communicate effectively with stakeholders.
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Clinical Trial Compliance Specialist
22 hours ago
Gandhinagar, India beBeeCompliance Full timeClinical Site Auditor RoleThis position involves guaranteeing adherence to standards and excellence at Clinical Trial sites.Key Responsibilities:Conduct audits of clinical research sites across phases I–IVReview CRFs, informed consent forms, and regulatory documentsIdentify and report audit findings; recommend corrective actionsSupport site staff with...
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Clinical Research Physician
3 days ago
Gandhinagar, India Micro Crispr Pvt. Ltd. Full timeMedical Oversight - Provide ongoing medical monitoring of assigned clinical trials, including real-time safety review of adverse events (AEs) and serious adverse events (SAEs). - Evaluate safety signals, trends, and laboratory/ECG abnormalities to ensure participant well-being. - Assess investigator-reported causality and provide independent medical judgment...
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Clinical Data Analyst
3 days ago
Gandhinagar, India beBeeStatistical Full timeSenior Statistical ProgrammerOur team is looking for a highly skilled Senior Statistical Programmer to join our Pharmaceutical and Biotech clients in driving the next generation of patient treatment. This exciting opportunity will see you fully embedded with one of our global pharmaceutical clients, supporting or leading Phase I-IV clinical trials. Data...
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Senior Clinical Data Analyst
3 days ago
Gandhinagar, India beBeeStatistical Full timeJob OverviewGenerate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple clinical studies.Develop SAS programs generating datasets, complex listings, tables (including descriptive and standard inferential statistics) in collaboration with a Statistician, and create graphs.Deliver high-quality statistical programming...
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Quality Assurance Auditor
1 week ago
Gandhinagar, India Eccentric Clinical Research Pvt Ltd Full time**Job Summary** We are seeking a Quality Assurance Auditor to join our reputable Contract Research Organization (CRO) and be responsible for ensuring the highest standards of quality and compliance in our clinical research activities. In this crucial role, you will play a key part in maintaining regulatory compliance, conducting audits, and driving...
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Clinical Compliance Specialist
3 days ago
Gandhinagar, India beBeeClinical Full timeWe are seeking a seasoned Clinical Quality Compliance Specialist to join our team.Job Title: Clinical Quality Compliance ManagerThe position entails ensuring compliance and quality at clinical trial sites through conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Main...
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Lead Clinical Data Analyst
3 days ago
gandhinagar, India beBeestatistical Full timeJob Opportunity: Statistical Programmer ExpertWe are seeking a highly skilled Statistical Programmer to play a crucial role in our clinical programming activities across multiple studies.Data Management: The successful candidate will be responsible for managing and maintaining clinical trial datasets and outputs using advanced data analysis...
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Senior Clinical Document Specialist
3 days ago
Gandhinagar, India beBeeRegulatory Full timeMedical Writer Job OpportunityWe are seeking a detail-oriented professional to join our scientific operations team in the medical device sector.About the Role:This is a full-time, site-based position on a 12-month fixed-term contract with the potential for extension. The Medical Writer will create, update, and manage regulatory and clinical documents...
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Lead Statistical Programmer
3 days ago
Gandhinagar, India beBeeStatistical Full timeThis is an exciting opportunity to lead a team of statistical programmers and drive the development of programming documentation, CDISC standards, and SAS programs. The successful candidate will have a strong background in clinical trial data processing, with expertise in SAS, R, and Python.Key Responsibilities:Lead the development of programming...
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SAS Developer
5 days ago
Gandhinagar, India HCLTech Full timeRole: Clinical SAS ProgrammerExperience: 3 years to 6 YearsLocation: Chennai, Noida, MaduraiNotice Period: Immediate to 30 Days (Not more than that)Skills: Clinical SAS, SDTM, ADaM DatasetsClinical Trials, performed clinical data analysis and generated SAS datasets in accordance with the SOP’s and guidelinesInterested candidates, please share the details...