Position Summary : This position will oversee the clinical trial process from start-up activities to site close out including onsite monitoring across a range of therapeutic areas.

Key Responsibilities :

- To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.

- In coordination with the project manager and/or medical monitor, perform study site qualification visits. Also to participate in/conduct investigator's meeting and site initiation visits.

- To identify, define, coordinate and conduct site study training.

- In coordination with the project manager, provide oversight of all study-related activities.

- To perform regular monitoring visits to site

- To ensure the compliance to ICH-GCP guidelines, local & international regulations (i.e. DCGI, FDA) and applicable SOPs.

- To verify the case report forms and source data according to the monitoring plan

- To ensure complete and accurate drug accountability

- To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.

- To ensure site level metrics in accordance to study monitoring plan or Quality plan (e.g. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate.

- Evaluates the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.

- To resolve all data queries or other study related queries from the site within timeframe.

- To prepare monitoring reports and post-visit documents.

- To follow-up for resolution of pending issues.

- Conduct site close out and assure appropriate archival of controlled documents.

- Provide inputs for preparation of site customized ICF.

- Maintain contacts outside the regular onsite visits, by appropriate communication means, to regulate or to motivate work to be performed by investigators or their staff. These contacts are always recorded and regularly transmitted to the project manager/project team.

- Plan travel and movements to the best cost efficiency and in respect of the general rules and procedures of the company.

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