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Clinical Scientist

Cambridge, MA 02139

Posted: 08/28/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 613774 Is job remote?: No Country: United States

Job Description

  • Work closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
  • Assist Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols and informed consent documents through incorporation of input from both internal and external experts
  • Assist with the annual update of IB with input from Toxicology, Pharmacology, Safety, Regulatory
  • Drive and integrates clinical contribution to answering regulatory queries and other submissions related to studies
  • Monitor and review along with the medical monitor safety and efficacy data in ongoing studies? monitors GCP compliance with help of clinical operations and CRO
  • Involved in high level data cleaning activities requiring clinical judgment Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
  • Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
  • Work with investigative sites to answer protocol related questions, resolve study conduct and design issues
  • May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
Requirements: 
  • Masters, PhD, or PharmD in related field
  • Allergy, Hematology, Oncology experience in a clinical setting
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About Cambridge, MA

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