Senior Clinical Research Scientist

6 days ago


Birch Run, Michigan, United States TechData Service Company LLC Full time
Job Title: Senior Scientist Clinical Research

This role will be responsible for leading the translation of scientific concepts into program and study design, including the integration of biomarkers, digital technologies, and data science initiatives. The ideal candidate will have a strong background in clinical development and experience with data visualization tools such as Tableau.

Responsibilities:
  • Lead the translation of scientific concepts into program and study design
  • Identify and implement non-medical scientific aspects of the program and/or study at planning, execution, and reporting
  • Oversee the assessment, selection, and operational implementation of biomarkers, digital, and other endpoints
  • Accountable for shaping and implementing compound and program DEI strategy
  • Provide expert input in clinical development plans
  • Contribute to the preparation of PED, study protocols, and training materials for clinical studies
  • Prepare for and participate in Protocol Review Committee (PRC) and First in Human (FIH) Committee meetings
  • Review medical and scientific literature
  • Responsible for the TA review and sign-off on various operational plans
  • Responsible for scientific input into HA and EC responses
  • Act as a liaison between the company and clinical investigators for overarching scientific guidance
  • Work closely with Data Sciences, Data Management, Statistics, Programming, JJIT, and others to ensure data are received in the manner needed to support trial outcomes
  • Responsible for the review of data to ensure quality and to identify data quality trends
  • Set up and lead Adjudication Activities
  • Lead data visualization (DV) meetings and ensure decisions are documented and communicated internally and externally
  • Own contracting with clinical consultants, IDMC members, and KOLs, including payment oversight
  • Participate in vendor oversight focusing on the integration of data and technology in clinical trials
  • Contribute to completion of clinical study reports
  • Contribute to the interpretation, reporting, and preparation of oral and written results of product research in concert with senior clinical personnel
Additional Clinical Research Responsibilities:
  • Partner with Regulatory Affairs in developing regulatory strategy and determining requirements for health authority reporting or corrective actions on trial/program level
  • May help explore and evaluate new assets (BD) and/or products to support compound value
Safety Management:
  • Oversee the set-up of medical review tools to meet medical review plan requirements
  • Participate in Data Review Meetings
  • Qualified CS may perform aspects of medical review under supervision of CL or SRP
  • Assist in organizing content for IDMC presentation
External Communication and Publication:
  • Contribute in all areas where scientific data will be generated and shared with the patients and/or the scientific community
  • May be asked to assess medical publications emerging from the Team and its affiliates
  • May act, in concert with senior clinical personnel, as the company spokesperson regarding publication of clinical research findings

PhD in relevant field (e.g. Neuroscience, Biomedical Sciences, Biology; pharmacy) or PharmD or MD degree from an accredited institution with 1-2 yrs work experience; or Masters in relevant field with 2-4 yrs work experience



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