Project Manager Post for Pharma Candidates @ Sun Pharma

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Project Manager Post for Pharma Candidates @ Sun Pharma
Pharma jobs for eligible candidates at Sun Pharma. Sun Pharma is hiring pharma candidates for project manager position. Check details on the same below:

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

Education:
  • UG -B.Sc – Any Specialization, B.Pharma – Pharmacy
  • PG – Any Postgraduate – Any Specialization, MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy

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