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2.0 - 6.0 years
0 Lacs
karnataka
On-site
The primary responsibility of the Clinical Systems Administrator is to provide business administration support for the Sponsor's clinical systems, including eTMF/CTMS, IRT, and EDC systems such as Veeva Clinical Vault and Medidata CTMS. You will collaborate with the Clinical Systems Manager/Sr. Manager and Project teams to ensure on-time deliverables and offer clinical systems user support. Key functions of the job include managing user access, data entry into the Global Directory, creation of studies, resolving help desk tickets, system modifications, process reviews, integrations initiation, archival steps, and ad-hoc task support. To qualify for this role, you must hold a degree or equiva...
Posted 2 months ago
5.0 - 9.0 years
0 Lacs
telangana
On-site
Preparation, review, and approval of investigation reports, risk assessment, impact assessment reports, and other required documents are key responsibilities in this role. You will handle product quality complaints (Adverse Event) related to Pharmacovigilance and market complaint investigations in CHEX system as per procedures, in coordination with the Pharmacovigilance team for adverse events. Additionally, you will manage the ENSUR system for the issuance and retrieval of SOPs, specifications, ATRs, worksheets, stability protocol management, BMR, BPR, BFR, as required. Ensuring document control, archival, retention, and destruction as defined in the procedure is crucial. You will also mana...
Posted 3 months ago
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