Glenmark Pharmaceuticals Limited
Mumbai – 400099
Mumbai – 400099
Job Description
Assists sites in adverse event reporting and recruitment strategies
Maintain and update trial master files on regular basis; Responsible for ensuring compliance to GCP, ICH Guidelines, regulatory and internal requirements for clinical trial master file documents.
Identifies, records and report quality problems to CPMs.
Suggests initiates, recommends and/or provides solutions as appropriate.
Assists the CPMs with completion of study specific tasks (such as preparation/shipment of study file notebooks)
Assist QA in preparation and review of the Clinical operation SOPs and their associated documents.
Assist CPMs in RFI and RFP process.
Review monitoring visit reports and update CPMs for any issues.
Facilitates the resolution of study related issues through communication with site personnel and clinical trial vendors including central labs, monitoring CROs, etc.
Assist in screening documents for Compliance with protocol and appropriate regulations, assist in investigating incomplete, in accurate or missing documents to ensure accuracy and completeness of data.
Performs other study related tasks as assigned by Clinical Project managers.
Explore new prospective sites and conducting feasibility survey for the studies.
Assist CPMs to manage Investigators meeting.
Assist CPMs in study start-up activities, regulatory process and execution of study related agreements.
Perform (or assist CRO’s CRA in) site Initiation, Monitoring and Close-out activities.
Perform study monitoring / compliance visit at CROs & sites.
Maintain ongoing communications with sites to provide information, queries resolutions, and overall progress of clinical trials and adherence to established guidelines.
Update CPMs with the sites and subjects status.
Review patient related logs and forms in-house.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Desired Profile
• Thorough understanding and experience in the complete gamut of activities in clinical operations, including ICH-GCP and various regulatory requirements
• Clear and thorough understanding of discovery processes, regulatory requirements and IP management.
•Excellent written and verbal communication skills, capable of interfacing with all levels in the company and stakeholders
•Pleasing personality, assertive profile with good inter-personal skills and hands on approach
Self starter / High on Team Working / Influencing skills / Maturity
Proactive, organized and flexible
Experience 2 - 6
Education UG - B.Pharma,B.Sc - Any Specialization, PG - M.Pharma - Pharmacy,M.Sc - Bio-Chemistry, Chemistry, Microbiology, Other
Location Navi Mumbai
Email hiring@glenmarkpharma.com
Website http://www.glenmarkpharma.com
.png)
0 Comments