Job Title: Project Manager
Experience : 5 – 10 Years
Location : Mumbai
- 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
- 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
- UG -B.Sc – Any Specialization, B.Pharma – Pharmacy
- PG – Any Postgraduate – Any Specialization, MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy