Sr. Clinical Scientist

Senior Clinical Scientist I
Therapeutic Areas: Oncology & Immunology
Description of Services

• May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.
  
• As lead, will be responsible for the following:

• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
  
• Responsible for trial design and endpoint development in collaboration with CD
  
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
  
• Sets up/supports SAC, DMC, adjudication committees
  
• Protocols/amendments collaborates with medical writer, participates in governance committee review
  
• Authors protocol clarification letters
  
• Contributor to study specific documents (e.g., SMP)
  
• Reviews/updates informed consent
  
• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
  
• Monitors data issues requiring clinical input
  
• Monitors central lab reports and other external data for safety and critical values
  
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
  
• Scientific lead on Clinical Trial Team (CTT)
  
• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system
  
• Coordinates planning of lab, bio specimens and imaging specifications
  
• Co- authors newsletters with SM
  
• Participates in Database lock activities
  
• Collaboratively plans CSRs, CTDs/WMAs with medical writing
  
• Supports publications/presentations as needed
  
• Reconciles and review all protocol deviation classifications in SPECTRUM
  
• Assesses and prepares protocol deviation list for CSR
  
• Collaborates with medical writing to develop trial results communication for investigators
  
• Provides scientific assessment for Operational Reviews
  
• Supports SM/MW activities as needed to achieve CTT deliverables.
  
• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
  
• May act as mentor to other CSs

Minimum FTE Years of Experience:

• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required.
  
• Medical monitoring experience required
  
• TA-specific experience beneficial
  
• Excellent Excel and PP skills required
  
• Excellent written and oral communication skills

Educational Requirements

• Degree in Life Sciences
  
• BS/BA/MS/PhD with 2+ yrs relevant career experience
  
• Degree in Life Sciences or significant experience in clinical development (>11years)
  
• BS/BA with 7+ yrs clinical research experience
  
• MS/PhD with 5+ years clinical research experience
  

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