Company

KCR

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Senior Director, Medical Operations

City/voivodeship

Warsaw (woj. mazowieckie)
Berlin (woj. zagranica)

Publication

2018-05-16

Company description

KCR is a Contract Research Organization (CRO) providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP) over a broad range of therapeutic areas. KCR operates across four main regions: North America (NA), Western Europe (WE), Central Europe (CE) and Eastern Europe (EE) with hubs located in Boston, US, Berlin, Germany, Warsaw, Poland and Kiev, Ukraine respectively. The company’s geographical set up suits perfectly to deliver optimized trial execution strategies for life-changing therapies.
For more information, visit www.kcrcro.com.
KCR: We see human behind every number.
A leading Contract Research Organisation (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Senior Director, Medical Operations. The new incumbent would gain an exceptional opportunity to lead a team of medical professionals and impact company's international operations in safety area. This is a permanent position based preferably in one of the company's Operational Hubs: Boston (US, Berlin (DE), Warsaw (PL) or Kiev (UA)
Location: Boston/Berlin/Warsaw/Kiev (home-based/office-based)
The duties associated with the role include:
 
  • Management of medical monitoring and high-level oversight towards pharmacovigilance and regulatory group
  • Responsibility for medical and ethical aspects of all clinical studies (ongoing studies and projects) carried out by KCR group
  • Active cooperation with Sales and Proposal Department in terms of development of company's service offering
  • Procides medical expertise to cross functional team, including support to safety cases processing and ensuring medical integrity of the data
  • Lead process alignment between all stakeholders involved in a clinical trial, particularly related to inquiry and clinical data flow and integration
  • Provide high level oversight to pharmacovigilance and regulatory groups, driving team developments and overall process compliance and improvement
  • Act as a leader of group of Medical Monitors, providing medical expertise, advice, and guidance in day-to-day medical management of clinical trials
  • Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) when such a Committee is constituted for a study
  • Participate in review and approval of study protocols and associated essential documents (e.g. informed consent form templates)
  • Participate in the review and interpretation of study data
  • Participate in the overall review and approval of final study reports
Requirements:
 
  • MD board-certification (PhD will be a plus)
  • Cross-therapeutic experience as Medical Monitor
  • Past or ongoing MD practice, enhanced with CRO background
  • At least 5 (five) years of industry experience in clinical research and at least 3 (three) years of industry experience in a managerial position, including business process and finance management


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