Senior Clinical Scientist Job Description

Senior Clinical Scientist Job Description Template

Our company is looking for a Senior Clinical Scientist to join our team.

Responsibilities:

  • Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards;
  • Support the writing of subsequent regulatory briefing documents;
  • Train CROs, vendors, investigators and study coordinators on study requirements;
  • Manage and oversee vendors for clinical studies;
  • Support inspection readiness and audits as required;
  • Develop and manage study timelines and budgets in collaboration with cross functional teams; mitigate challenges that occur;
  • Communicate with functional peers regarding project status and issues and ensure project team goals are met;
  • Plan and participate in conduct of Investigator Meetings;
  • Participate in vendor and site audits as needed;
  • Collaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendors;
  • Ensure high quality internal Clinical Operations databases and document repositories;
  • Fulfill Clinical Project Lead (CPL) responsibilities, as assigned;
  • Support management in multiple departmental or interdepartmental strategic initiatives;
  • Recruit, hire, manage, mentor, and develop junior staff members (e.g., Clinical Scientist, CTA), as assigned;
  • Thorough understanding of FDA regulations, GCP/ICH guidelines, and ISO requirements is required.

Requirements:

  • MEDICAL SURVEILLANCE Yes;
  • Medical device experience a plus;
  • MS Office Suite proficiency (Word, Outlook);
  • Regulatory Affairs experience a plus;
  • DIVISION SH Structural Heart;
  • SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day);
  • Experience with vaccines highly preferred;
  • Job id: 30944082;
  • Therapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Oncology, or Women’s Health;
  • LOCATION United States – Minnesota – Plymouth;
  • TRAVEL Yes, 10 % of the Time.