vacancies

Conduct in-process and retrospective audits for studies and method validations. Review reports, source data, audit trails and regulatory compliance. 

Ciron has carved a niche for itself in the sphere of operations of manufacturing Ampoules, Vials, Eye / Ear / Nasal drops, Lyophilized products and Lyophilized bulk. Manufactured in India

Serves as a Clinical Data Reviewer and identify any errors in data by performing data review per DRP and issuing/closing queries.

Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business.

Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.

Responsible for preparing lower complexity documents such as synoptic or abbreviated CSRs under guidance of more senior staff. Assist Medical Writers in the preparation and background writing of clinical study protocols, CSRs, and subject narratives.

Contributes, with appropriate oversight, to all relevant aspects of global clinical trial activities to deliver study outcomes within schedule, budget, quality, compliance and performance standards. May lead specific aspects of global clinical trial. High quality contributions to study documents e.g. protocol, ICF, clinical sections of CTA -Clearly demonstrates Novartis Values and Behaviors i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.

Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision.

Performs E2E process related scientific writing that includes but not limited to manage workflow in PubConnect, create publication plan, author approvals, pre-submission queries, submission activities etc.