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Details

Senior Clinical Scientist


Reference:SR-A009584 Location: Clonmel
Qualification:MastersExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Services Manager


Our client is an established Life Sciences Consultancy, currently growing their service provision in the Clinical sector.

Are you a Medical Doctor seeking to apply your expertise and skillset in a different way?
Are you a senior Clincial Scientist currently looking for a different challenge?

If you have answered yes to either of the above and you are looking for a remote working opportunity working with a diverse portfolio of clients, then we would like to hear from you...

Our client is also open to a part-time option, fully negotiable dependent on the candidate

  • Advanced degree (MD, PhD, PharmD or MSc)
  • Strong commercial awareness & an innate ability to assess the commercial implications of decisions & advice.
  • 1-3 years’ experience as a Clinical Scientist or Medical Manager.
  • Experience in clinical development, including study start-up and clinical trial execution, clinical report writing for medicinal products and medical devices.
  • Experience with global pharmacovigilance legislation.
  • Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage, understanding of the regional regulatory procedures for CTAs.
  • Influence and work with clinical/regulatory staff to outline specifics of clinical trial design.
  • Adaptability to changing landscape and ability to pivot quickly with new client work demands.
  • The attitude and ability to be effective in a lean, small company environment.
  • Above average communication skills both written and oral, with the ability to influence at a senior level


PURPOSE / KEY RESPONSIBILITIES:



Clinical
  • Day to day contact directly with KOLs, CRO’s, investigators, study coordinators, and other HCPs - as defined by territory.
  • Interacts with global regulatory bodies including the EMA, FDA to accomplish tasks related to new products in product development and oversee the clinical research plans and dossier sections for new drug applications.
  • Plans and manages the project timelines to ensure client clinical studies are conducted in a timely manner and within the project budget.
  • Delivery of / review of medical and scientific materials, educational materials and programs, scientific symposia.


Pharmacovigilance / Device Vigilance:


  • Assist with the review of Risk Management Plans (RMP’s), Signal Detection Reports, Periodic Safety Update Report’s (PSURs) etc.
  • Assist in the review of medical device incident reports in association with the Medical Device/Quality team and assessment of associated risk.
  • Works closely and effectively with cross functional teams to ensure consistency between highly linked documents: risk analysis, clinical evaluation report, PMCF plan & activities, PMS reports and IFU.
  • Analyse data, identify performance trends and take action to improve and sustain performance levels.
  • Support quality, regulatory and other personnel outside of clinical function