Invitro Invivo Biology

Role: Expert - Invitro Biology

Direct Reporting: Director Clinical Research Functional

Job Purpose:

Project manage Clinical Trials through CRO's/Institutes at all stages of the clinical study Monitor/Audit clinical trials at the sites/ CRO Ensure robust quality data from the clinical trials

Accountability:

No. of clinical studies successfully completed and commercialized • Studies completed within designated timelines • Cost saving achieved in the study budget

Key Accountabilities :

• Assist in identification of appropriate CROs and third-party study vendors for the conduct of clinical studies
• Assist in preparation and review of clinical protocols, amendments, informed consent forms, study guides, case report forms, clinical study reports and any other clinical research related documents
• Continuous interaction and evaluation of CROs, third party vendors, and field CRAs to ensure compliance with study protocol and in accordance with scope of work
• Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial
• Training CRO staff/ site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
• Monitoring the trial throughout specified duration involving monitoring visit to the trial sites
• Perform audit on all clinical trial documents and update all central clinical files and evaluate all reports and resolve all site associate issues
• Responsible for managing clinical and non-clinical supplies to the site/ CRO/ labs including study investigational products, blood samples etc.
• Tracking and reporting on progress of study including site initiation, subject enrollment, monitoring visits
• Tracking of clinical trial budgets, study invoices, payments to vendors
• Collaborate with various teams for research activities and assist in vendor management
• Responsible for ensuring Trial Master Files are updated at the site/ CRO/ in-house
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Maintain surveillance of published literature and clinical studies on health benefit categories

Education:

• B. Pharm/ M. Pharm / P.hd

Experience:

• 0 - 5 years with experience with exposure to clinical studies