Clinical Research Project Manager Post Vacant @ Sun Pharma

Job Title:    Project Manager

Experience : 5 – 10 Years

Location : Mumbai

Job Description:

• To Plan study milestones, timelines, resource requirements and handle studies during their lifecycle.
• Plan IP and trial material requisition.
• Train and mentor monitors On-site for trial related actions
• Facilitate and organize with operations staff for EC submission and acceptance.
• Make sure conuct of site identification, feasibility and eligibility visits in a timely way.
• Coordination with operations staff and websites for implementing clinical study agreements, financial arrangements.
• Prepare clinical trial funding and receive management approval after negotiation
• Initiate seller contract and negotiate prices for solutions where applicable.
• Meet researchers and key opinion leaders for trial project.
• Establish timelines and trackers for clinical trial project.
• Train track and inhouse staff on trial and most of critical documents.
• Coordinate for SIVs using Operations staff and websites
• Track advancement of trial per preset timelines and send weekly updates to direction
• Ensure recruiting timelines are met.
• Within a continuous process during trial, take corrective and preventative actions to guarantee GCP compliance and trustworthiness of information.
• Resolve inquiries and problems of websites and with sellers.
• Guarantee timely reporting of SUSARs to regulatory authorities and reporting of SAEs to all investigators and sites.
• Make sure trial document archival in websites, inhouse, or by third party as important.
• Make sure inhouse trial document finishing after all actions needed for the identical viz. Finished IP destruction logs and CSR reception acknowledgement by EC is got.
• Train freshers on SOPs as stipulated.
• Prepare training schedule for new joinees as important and run training as important.
• Oversee SOP revisions and composing of new SOPs as important.
• Socialize with Clinical specialists for routine development and scientific question resolutions together with medical advisors .
• Coordinate with other division employees linked for related tasks to ensure timely operation viz. FDD for IP,
• Legal for arrangements, Accounts for obligations, RQA for SOPs
• Motivate staff and promote bonding and interaction within staff
• Make compliance with GCP and Regulatory demands for many studies conducted by ICR

Experience:

• On-site Tracking experience- Minimum 5 years
• Project Management experience- Minimum 3 years
• Expertise of hosting – Regulatory inspections and Sponsor audits
• Expertise of developing CAPA (Corrective actions and Preventive action) and execution of the Exact Same

Qualifications: 

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