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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Clinical Trial Physician - Phase I, Client-dedicated

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A Medical Doctor degree is required.
  • Excellent written and spoken English is required.
  • Ability to travel is required.
  • Interpersonal skills to lead a study team, recognize individual expert competencies, provide medical advice and evaluations, and judge which issues require immediate escalation.
  • Problem-solving and negotiation skills, with sensitivity to cultural needs in a global organization.
  • Communication skills to collaborate with cross-functional team members, make study plans and status transparent, and clarify risks, issues, and results.
  • Skills in gathering decision information, negotiating, communicating decisions, and communicating actions in a matrix structure.

Responsibilities

  • Provide medical leadership to study teams, including creating clinical trial protocols using current scientific information and contributing to site selection.
  • Contribute to review and approval of study protocols and amendments, Clinical Study Reports, Informed Consent Forms, Case Report Forms, protocol deviation decisions, and other clinical documents needed to conduct trials.
  • Provide real-time medical monitoring of clinical studies, ensuring the medical validity of each primary endpoint and the safety of study subjects, and identifying medical issues early.
  • Escalate and correct issues proactively in consultation with the Global Medical Indication Lead.
  • Interpret clinical trial data for regulatory documents, manuscripts, and other publications in consultation with the Indication Lead.
  • Serve as the medical point of contact for internal and external stakeholders and interact with investigators as needed.
  • Answer questions from institutional review boards and health authorities.
  • Prepare and present material to the study executive and independent safety committee, if applicable.
  • Provide medical training to site staff at investigator meetings and train clinical research associates in new indications.
  • Ensure compliance for all medical aspects of studies by understanding and applying relevant standard operating procedures and Good Clinical Practice.
  • Collaborate closely with cross-functional study team members to ensure medical risks, issues, and results are clear to all involved parties.
  • When multiple physicians work on a protocol, serve as primus inter pares when appointed and harmonize responses to site, institutional review board, and regulatory authority questions, eligibility decisions, and protocol deviation decisions.

Desired Qualifications

  • Relevant specialty education, such as neurology, hematology, dermatology, immunology, rheumatology, internal medicine, or pediatrics.
  • Some experience in industry.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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