Clinical Research Project Manager Post Vacant @ Sun Pharma

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Clinical Research Project Manager Post Vacant @ Sun Pharma

Clinical Research Project Manager Post Vacant @ 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 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: 

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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