eClinical Systems Analyst
4 weeks 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
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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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
3 days ago
Pune, Maharashtra, India TransPerfect Full time ₹ 5,00,000 - ₹ 15,00,000 per yearJob description OVERVIEWThe 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...
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Business Analyst
3 weeks 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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LabVIEW System Engineer
1 week ago
Pune, India ARAV Systems Full timeJob Description About the Company ARAV Systems Private Limited is a System Integration & Automation Firm serving customers around the globe. Job Specifications: - Experience: 2-4 years expertise in LabVIEW. It is preferred to have knowledge of other programming languages like Python, MATLAB, .NET etc. - Location: Pune - Salary: Pay is commensurate with...
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Data Governance
4 weeks 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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Data Governance
4 weeks 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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Senior Systems Analyst
3 days ago
Pune, India Mastercard Full timeJob Description Our Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and...
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Business Data Analyst
4 weeks ago
Pune, India Systems Plus Full timeJob Description SystemsPlus is hiring for : R&D IT Business Data Analyst : Life Science Exp : 7 yr + Location : Pune - Magarpatta. Hybrid. Position Summary: We are seeking a highly motivated and detail-oriented R&D IT Business Data Analyst to serve as a critical liaison between IT, R&D, and cross-functional teams in the Biotech Industry. This role supports...
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Business Analyst
4 weeks ago
Pune, 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, Java What You'll Do: Good experience in documenting requirements along with acceptance...
