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Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.
Clinical Research
About Me
Industry: |
Science & Biotech |
|---|---|
Occupation: |
Clinical Research |
Education level: |
Master |
Will Relocate: |
Yes |
Keywords
Develop, maintain and manage appropriate study documentation, Developing, writing and presenting the clinical trial protocols, Initiate, maintain and reconcile Trial Master File., Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise., Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data., Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines, Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines., Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
