Sun Pharmaceutical Industries Ltd
Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.
Job Title: Project Manager – Clinical Research
No. of Posts: 1
- 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