Manauwar Alam

  • Dubai Dubai
Manauwar Alam

Sr.Clinical Research Coordinator

Work History

Work History
Jan 2011 - Apr 2015

Sr Clinical Research Coordinator

Mahavir Hospital & Research Center

Comapany: Hyderabad, India Designation:. Sr Clinical Research Coordinator Duration: Key Accountabilities & Skills Ensuring that the site personnel are adhering to the clinical protocols and address any issues concerning clinical protocol non-compliance with the principal investigator. Provide ongoing training to the Study Staff with regards to ICH-GCP guidelines and SOPs to ensure the quality and integrity of the data. Responsible for ensuring patient's safety by maintaining accurate records of adverse events, concomitant medications, abnormal laboratory result, and out of range vital signs readings. Ensure that documents are collected in a timely manner in order to meet regulatory and ethics committee/IRB submission dates. Prepare and/or draft all recruitment related templates to add any site-specific information to the templates before using. Maintain project tracking system(Clinical Trial Management System, Patient Recruitment Plan) on an ongoing basis to ensure that progress regarding the sites can be tracked. Assist with the audit of an investigational site and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines. Build and maintain good and effective relationships with Sponsor/CRO. I have faced 5-DCGI inspection & 6-Sponsor audit without any critical finding. Therapeutic Expertise: Phase III-Fibromyalgia Phase III-Systemic Lupus Erythematosus

Apr 2010 - Dec 2010

Clinical Research Coordinator

Active Ankolosing Spondilytis
Phase III- Comapany: Mahavir Hospital & Research Center, Hyderabad, India Designation: Clinical Research Coordinator Duration: Key Accountabilities & Skills Facilitated Principal Investigator in consenting process and ICF procedures Sourced data collection and verification Conducted verified and follow up of patient visits as per clinical protocol requirements Archived trial related documents and transformation of clinical trial information into Trial Master file/Investigator Site Binder. Data collection, Query resolution, verification, data entry on Case Report Forms(eCRF) using different clinical data bases(Inform/Phase forward, OCRDC/Oracle Data management). Verification of technical compliance of clinical submission documents related to clinical trials. Communicated with Institutional Ethics committee for regulatory documents submission, reporting of Adverse Events(AE) s & Serious Adverse Events(SAE) s. Resolved the Data Clarification Forms(DCF). Investigational Medical Product(IMP) dispensing through IVRS(Interactive Voice Response System) and IWRS(Interactive Web Responsive System), drug accountability. Drug accountability in accordance with ICH GCP guidelines. Therapeutic Expertise: Phase II-Active Rheumatoid Arthritis

Education

Education
2009 - 2010

Diploma

Academia of
2006 - 2009

B.Sc

Punjab Technical University