eClinical Systems Analyst
1 week ago
Job Description OVERVIEW The eClinical Systems Analyst has good knowledge of clinical trial processes and associated systems utilized. With core skills around Trial Master File (TMF) processes they work as support to Study Owners to ensure a complete, contemporaneous and accurate TMF across our clients clinical trials and programs. The eClinical Systems Analyst is responsible for assisting clients with the development, maintenance and closeout of clinical trials, using a number of eClinical systems including but not limited to:- e (electronic) TMF, Study Start up (SSU) and Clinical Trial Management System (CTMS). The person in this position will be someone who is experienced with eClinical systems, particularly the clinical trial process including management of the TMF. DESCRIPTION Work with Study Owners with all start up, maintenance and close out activities in regards to the TMF eTMF ongoing user management May be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMF Create and complete TMF quality reviews to ensure document content and metadata application are accurate and to ensure documentation is present/complete in the TMF Communicate all systematic filing issues to the manager for further training evaluation Periodic quality reviews for each active study site for all regulatory documents, including: Institutional Review Board (IRB) Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, College of American Pathologists (CAP), Clinical Laboratory Improvements Amendments (CLIA), 1572 Form, Agreements, Principal Investigator (PI) CVs Draft, review and approve TMF Quality plans and reports and reconciliation of findings Assist in regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines Identify and report to Study Owner, Clinical Document Lead, Project Manager, Client and, or Manager on TMF trending issues/concerns, determining resolutions and course of actions Provide support on metrics and report preparation for TMF Key Performance Indicators (KPIs) - completeness, quality and timeliness Storyboard support and maintenance to assist with inspection readiness Clinical Trial Management System (CTMS) data entry and analysis on behalf of CTMS and enterprise clients Meeting minutes and agendas Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor.
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eClinical Systems Analyst
2 weeks ago
Pune, Maharashtra, India TransPerfect Full time ₹ 9,00,000 - ₹ 12,00,000 per yearOVERVIEW The eClinical Systems Analyst has good knowledge of clinical trial processes and associated systems utilized. With core skills around Trial Master File (TMF) processes they work as support to Study Owners to ensure a complete, contemporaneous and accurate TMF across our clients' clinical trials and programs. The eClinical Systems Analyst is...
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eClinical Systems Analyst
1 week ago
Pune, Maharashtra, India Transperfect Full time ₹ 5,00,000 - ₹ 12,00,000 per yearOVERVIEWThe eClinical Systems Analyst has good knowledge of clinical trial processes and associated systems utilized. With core skills around Trial Master File (TMF) processes they work as support to Study Owners to ensure a complete, contemporaneous and accurate TMF across our clients' clinical trials and programs. The eClinical Systems Analyst is...
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Business Analyst
8 hours ago
India Hirenza Full timeJob Description About The Company Octalsoft LLC is a leading technology solutions provider specializing in delivering innovative software and consulting services to the healthcare and life sciences sectors. With a strong focus on clinical research, data management, and regulatory compliance, Octalsoft LLC is committed to empowering organizations with...
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Sr External Data Specialist
2 weeks ago
Bengaluru, India eClinical Solutions Full timeJob Description eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one...
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Business System Analyst
4 weeks ago
India Insight Global Full timeRequired Skills & Experience -4+ years experience as a System or Business System Analyst - Understanding of XStore or POS - with experience of end to end integrations of XStore with other systems - Experience with data flow, database tables and field mappings. - splunk configurations - Note JS or python - java - AWS Lambda - SQL -...
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Business Analyst
2 weeks ago
india Persistent Systems Full timeAbout Position:Over 8+ years of IT experience and 5+ years as Business Analyst with good written communication skills- Role: Business Analyst - Location: Pune, Hyderabad - Experience: 8 to 12 YEARS - Job Type: Full Time Employment - Mandatory Mention 3 skills: No SQL, Angular JS, JavaWhat You'll Do:- Good experience in documenting requirements along with...
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Data Governance
6 days ago
india, IN Sky Systems, Inc. Full timeWe’re looking for a detail-oriented Data Governance & Systems Analyst to support global content operations. The ideal candidate will act as a digital librarian, maintaining data accuracy, structure, and hierarchy within Rightsline and related systems.Key Responsibilities:Maintain and organize Rightsline metadata, ensuring title hierarchy accuracy.Monitor...
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System Analyst
3 weeks ago
Bengaluru, India Insight Global Full timeJob Description Employment Type: Salaried role with Benefits, PF Location: 2-3x a week in Bangalore Duration: 6 month contract with extensions - expected to be long term Joining Date: Must be within30 days Working Hours: 40 HRS/ week Pay Range: 15-20 LPA Required Skills & Experience - Has around 5 years of experience in a Systems Analyst role or...
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Data Governance
4 days ago
India Sky Systems, Inc. (SkySys) Full timeWe’re looking for a detail-oriented Data Governance & Systems Analyst to support global content operations. The ideal candidate will act as a digital librarian , maintaining data accuracy, structure, and hierarchy within Rightsline and related systems. Key Responsibilities: Maintain and organize Rightsline metadata, ensuring title hierarchy accuracy....
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Business Analyst
3 weeks ago
india Persistent Systems Full timeAbout Position:Over 8+ years of IT experience and 5+ years as Business Analyst with good written communication skillsRole: Business Analyst Location: Pune, Hyderabad Experience: 8 to 12 YEARS Job Type: Full Time Employment Mandatory Mention 3 skills: No SQL, Angular JS, JavaWhat You'll Do:Good experience in documenting requirements along with acceptance...
