Executive / Assistant Manager - Clinical Operations (Clinical Research Associate)
Job details
Position Title : Executive / Assistant Manager - Clinical Operations (Clinical Research Associate) Location : Bangalore At VIATRISâ„¢, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via :
- Access – Providing high quality trusted medicines regardless of geography or circumstance.
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.
- Function as monitoring lead for assigned clinical Phase I-IV studies. Serve as liaison between the Mylan project team (Global Clinical Operations, Data Management, Clinical Science, Quality Assurance, etc.), Clinical Research Organizations (CROs), and clinical investigators regarding study activities to include the scope of the clinical study; data review, project time lines, and requests for documentation.
- Perform comprehensive data management tasks and monitoring functions. Assist in the preparation of project plans and provide project reports to management as needed. Conducts data review, writing reports and resolving data clarifications.
- Function as clinical data reviewer for multiple Phase I-IV focused CROs with responsibility to oversee assigned projects assigned to that CRO. Ensure the CRO is compliant with assigned study protocols, overall clinical objectives, GCP, SOPs and applicable federal, state and local requirements. Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with Mylan document control procedures for assigned studies.
- Review clinical and drug product documents for accuracy, completeness and timeliness internally and at the research sites. This includes review of completed source documents (including eDiary, DCFs, NTFs, etc.), Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form (CRF) templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations, completed CRFs and Clinical Reports.
- Conduct clinical monitoring of studies remotely and on-site as required according to Mylan SOPs and Clinical Monitoring Plan (CMP). This includes visit preparation, monitoring process, completion of the monitoring report, visit follow-up activities and travel to and from the clinical locations.
- Interview clinical site research personnel in follow-up of monitoring visits and data issues. Communicate any substantial findings to his/her supervisor and clinical investigator during or immediately following a monitoring visit. Monitor and/or follow-up on the implementation of corrective action plans following clinical site inspections or audits, as required.
- Develop and review SOPs where required. Responsible for identifying improved operational methods for functional area.
- Oversee and assist in training of new Clinical Data Reviewer where required.
- Perform other duties as assigned.
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