Project Manager Post for Pharma Candidates @ Sun Pharma

Job Title:    Project Manager

Experience : 5 – 10 Years

Location : Mumbai

Job Description:

• To Plan study milestones, timelines, resource requirements and manage studies throughout their lifecycle.
• Plan IP and trial material requisition.
• Train and mentor monitors On-site for trial related activities
• Facilitate and coordinate with operations team for EC submission and approval.
• Ensure conuct of site identification, feasibility and qualification visits in a timely manner.
• Coordination with operations team and sites for executing clinical study agreements, financial agreements.
• Prepare clinical trial budget and get management approval after discussion
• Initiate vendor contract and negotiate costs for services where applicable.
• Meet investigators and key opinion leaders for trial project.
• Set timelines and trackers for clinical trial project.
• Train monitor and inhouse team on trial and all essential documents.
• Coordinate for SIVs with Operations team and sites
• Track progress of trial per preset timelines and send weekly updates to management
• Ensure recruitment timelines are met.
• In an ongoing process during trial, take corrective and preventive action to ensure GCP compliance and reliability of data.
• Resolve queries and issues of sites and with vendors.
• Ensure timely reporting of SUSARs to regulatory authorities and reporting of SAEs to all sites and investigators.
• Ensure trial document archival at sites, inhouse, and/or by third party as applicable.
• Ensure inhouse trial file closure after all activities required for the same viz. completed IP destruction logs and CSR receipt acknowledgement by EC is obtained.
• Train freshers on SOPs as designated.
• Prepare training schedule for new joinees as applicable and conduct training as applicable.
• Oversee SOP revisions and writing of new SOPs as applicable.
• Interact with Clinical experts for protocol development and scientific query resolutions along with medical advisors .
• Coordinate with other department personnel linked for related activities to ensure timely performance viz. FDD for IP, Legal for agreements, Accounts for payments, RQA for SOPs
• Motivate team and encourage interaction and bonding within team
• Ensure compliance to GCP and Regulatory requirements for all studies conducted by ICR

Experience:

• On-site Monitoring experience- Minimum 5 years
• Project Management experience- Minimum 3 years
• Experience of hosting – Regulatory inspections and Sponsor audits
• Experience of developing CAPA (Corrective action and Preventive action) and implementation of the same

Qualifications: 

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