Post Approval Studies Manager


 
About the Client
Our client is a top 10 pharmaceutical MNC with an open-minded and welcoming company culture with a variety of product portfolio in specialty care and primary care.

Role's Responsibilities
  • Lead operations of the company's post-approval studies, including NIS, IIR, ensuring medical compliance and governance and the quality of deliveries.
  • Overseeing site activities and processes for NIS trials to make sure sites are high-quality, follow rules, work well, and are effective.
  • Handles Site Management budget, including external clinical grants, for all costs related to applicable NIS and IIRs.
  • Makes sure there's enough resources for each trial to run smoothly.
  • Works closely with MA and MSLs from relevant areas to make studies successful.
  • Manages contracts, works with vendors, takes care of budgets, and helps organize patient support programs with input from the Medical Advisor in charge.
  • People manager of 2 members.

Qualifications
  • BS degree in a science or healthcare-related degree.
  • 5+ years of work experience in clinical trials or clinical operations knowledge of ICH-GCP and applicable legal, compliance and regulatory requirements.
  • Experience in MNC pharma is a plus.
  • A hands-on team player with people management experience.
  • Good administrative, financial, technical skills, and great English communication skills to work effectively with internal and external stakeholders.
  • Innovative and creative mindset.

Qualified and interested Parties please apply with your CV in Word format to
ivy.chi@fyte.com
Please note, that while Morgan Philips Group welcomes and appreciates all candidate response, volume of replies allows us to respond to short-listed candidates only. Resumes are collected for recruitment purposes only.

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