Research Scientist PI – Bioanalytical
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • Virginia • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Acts as sponsor representative/study monitor for several studies
- Supports bioanalytical phases of clinical trials
- Reviews trial documentation and ensures the bioanalytical vendor receives required documents
- Reviews and approves study plans and reports
- Manages changes to study plans and vendor procedures, documenting them per requirements
- Ensures clinical trial team is informed about project status
- Escalates issues related to timelines, budget or communication
- Manages oversight documentation in eTMF
- Contributes to interactions with regulatory agencies
Requirements
- PhD in Immunology or Molecular Biology (3+ years experience) or Master's Degree in life sciences (6+ years experience)
- Experience in managing outsourced activities at external vendors
- Strong knowledge of bioanalytical techniques in biologics and antibodies assays
- Experience performing PK and ADA assays
- Experience analyzing human samples in support of clinical trials
- Strong understanding of GCP/GCLP guidelines and other global regulations
- Experience with submission documentation and regulatory interactions
- Experience with clinical immunogenicity data interpretation and writing clinical study reports
- Ability to draft and review bioanalytical modules and regulatory documents independently or with a medical writer
Benefits
- Standard work schedule (Mon-Fri)
- Comprehensive background check including drug screening
- Full-time benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
bioanalytical techniquesPK assaysADA assaysclinical trial documentationregulatory document writingclinical immunogenicity data interpretationstudy plan managementvendor managementeTMF managementbioanalytical module drafting
Soft skills
communicationproblem-solvingproject managementteam collaborationissue escalationorganizational skillsindependent workattention to detailinterpersonal skillsleadership
Certifications
PhD in ImmunologyPhD in Molecular BiologyMaster's Degree in life sciences