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Über diese Clinical Trial Physician - phase I (client-dedicated), EMEA Stelle bei Thermo Fisher Scientific

Thermo Fisher Scientific · Remote · Remote, Belgium

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

As a Clinical Trial Physician you will provide clear medical leadership in the Study team,  working  in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget  .

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You'll Do:

  • Provide medical leadership  to the study teams , including creating clinical trial protocols while  implementing the latest scientific information, contribute to site selection ,  contribute to review and approval of  study protocols and  amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
  • Real time Medical Monitoring of clinical studies:   ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction  of issues  in consultation with the Global Medical Indication Lead
  • Interpret the   clinical trial  data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
  • Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities,  prepare and present material to   the study executive and independent safety committee if  applicable;  medical  training of site staff at Investigator meetings;  CRA training in new indications
  • Ensure study compliance for all medical aspects  by understanding and applying all relevant SOPs and GCP
  • Closely collaborate  with the cross functional study  team members in order for  medical  risks, issues, and results to be  clear to all involved parties
  • In case more than 1 physician is working on the protocol , a primus inter pares will be appointed and he/she will ensure that  answers to questions  from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics .


Education and Experience Requirements:

  • Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine,  pediatric, )
  • Some experience in industry preferred

.

Knowledge, Skills, Abilities:

  • Excellent English, both written and spoken  is a must, as well as ability to travel.
  • Proven  interpersonal skills enabling to lead a study  team,  while recognising individual expert competencies, providing  medical advice and evaluations exercising  judgement in which issues need to be escalated immediately  
  • Pro-active problem solver with negotiation skills ,  remaining sensitive to the different  cultural needs in a global organisation
  • Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties.  A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action.


Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Why join us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

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Über Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosyste

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