SIRO Clinpharm Pvt. Ltd Released Job Openings On 29/07/2022.Siro Clinpharm is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in clinical trial management, clinical data management, medical writing, biostatistics & statistical programming & pharmacovigilance. In 1996 Dr.Gautam Daftary founded SIRO in Mumbai, India. In 2001 company started providing its services in Data Management.
SIRO Clinpharm Pvt. Ltd Recruiting Candidates with 06+ years of experience for Clinical Team Lead – (Principal CRA – Onsite Monitoring) Position.Complete Details for the Clinical Team Lead – (Principal CRA – Onsite Monitoring) as follows.
Important Details :
- Location :Hyderabad/Secunderabad, Mumbai (All Areas)
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application: 29/07/2022
- Mode of application :Online
- How To Apply: Interested candidates can send CV to email@example.com
Job Description/Skills Required
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. a) Site Monitoring
- 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 investigators 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 v To ensure the compliance to ICH-GCP guidelines, local & international regulations (i.e. DCGI, FDA) and applicable SOPs. v To verify the case report forms and source data according to the monitoring plan v 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.