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.