30 Jul
|
Inductive Quotient Analytics
|
Mahbubnagar
30 Jul
Inductive Quotient Analytics
Mahbubnagar
Job Title: Clinical Database Designer (2–3 Years Experience)About Inductive Quotient Analytics Pvt Ltd.Inductive Quotient Analytics is a fast-growing CLIN Tech CRO that was founded with a singular commitment to help life sciences - pharmaceutical, biotech, nutraceutical and healthcare companies simplify, accelerate and scale their clinical trials to reduce time-to-market through streamlined delivery of novel treatments and medical innovations to patients.We offer end-to-end biometrics services – Biostatistics, Clinical Data Management, Statistical Programming and Clinical Programming, along with Real World Evidence and HEOR. We also have a solid medical affairs team that takes care of Medical Writing and Medical Coding.Our product engineering arm has built an AI-based homegrown solution to accelerate clinical trials. It enables global pharma and biotechnology companies to swiftly conduct clinical trials with high efficiency and achieve faster approvals.Visit our website:Roles & Responsibilities:- Design and develop Electronic Case Report Forms (eCRFs) based on clinical study protocols, CRF specifications, and study requirements using Medidata Rave, Veeva Vault CDMS, and other EDC platforms.- Provide technical inputs and recommendations during the database setup and development phase of clinical studies.- Configure and manage in-house and third-party integrations including IXRS/IWRS and external vendor integrations.- Perform programming activities including:- Dynamics configuration- Derivations- Edit checks programming- Data validation rules- Perform Lab Module setup and configuration within EDC systems.- Conduct peer review, testing, and validation of database programming activities and eCRF builds.- Collaborate with Sponsors, Clinical Data Managers, and study teams for eCRF review, feedback incorporation,
and database optimization.- Ensure compliance with best practices, SOPs, standards, and clinical data management guidelines.- Demonstrate strong understanding of Clinical Data Management (CDM) processes, 21 CFR Part 11, ICH-GCP guidelines, and regulatory requirements.- Ensure all programming activities, documentation, and data acquisition processes are high quality, audit-ready, and compliant with regulatory standards.- Perform data extraction activities and support CDASH standards implementation.- Manage end-to-end activities including:- Database design specification- eCRF development- Programming- Testing- Validation- Dataset extraction- Analyze complex technical issues, provide recommendations, and implement effective solutions.- Maintain knowledge of regulatory requirements related to electronic submissions and clinical trial data standards.- Support audit readiness by maintaining proper documentation and ensuring adherence to data acquisition procedures.- Manage multiple clinical studies/projects simultaneously while ensuring timely delivery and meeting project milestones.Required Skills & Experience:- 2–3 years of experience in EDC Programming / Clinical Database Design.- Hands-on experience with Medidata Rave, Veeva Vault CDMS, or other EDC platforms.- Strong knowledge of:- eCRF development- Edit checks- Dynamics- Derivations- Lab Module configuration- Data extraction- Validation processes- Good understanding of Clinical Data Management workflows and clinical trial lifecycle.- Knowledge of CDASH standards, 21 CFR Part 11, ICH-GCP, and regulatory compliance requirements.- Experience in database testing, peer review, and validation activities.- Ability to work with cross-functional teams including Sponsors, Data Managers, and Clinical teams.- Strong analytical, documentation, and problem-solving skills.
📌 Clinical Database Designer (Mahbubnagar)
🏢 Inductive Quotient Analytics
📍 Mahbubnagar