Clinical Safety Scientist (Program-Level Data Review)
Clinical Safety Scientist (Program-Level Data Review)
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Randstad Life Sciences US provided pay range
This range is provided by Randstad Life Sciences US. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$100.00/hr - $120.00/hr
Contract through 12/31/25 (extension possible)
Part-Time/Flex (~20 hrs/week)
REMOTE | W2 or 1099
Seeking a seasoned Clinical Safety Scientist to lead program-level safety data review for a large Phase III program at a biotech company. Note: This is not a PV Ops role (no ICSR processing, signal detection, aggregate reporting, vendor management)
MUST HAVES
- Advanced degree required (PhD, PharmD, or MD preferred; MS minimum)
- Experience in mid-to-large pharma or biotech, with Phase III trial experience
- Proven ability to lead end-to-end safety data review, from collection through analysis, presentation, and discussion with leadership
- Strong scientific writing and data interpretation skills, including safety narrative review
- Effective collaborator, able to align with medical monitors and support IDMC/SMTpreparation
- Thrives in fast-paced, autonomous environments
ROLE
- Conduct in-depth clinical trial safety data review and analysis across multiple ongoing Phase III studies
- Lead preparation of safety data summaries and slide decks for internal leadership and Safety Management Team (SMT) presentations
- Collaborate with medical monitors to ensure medical accuracy and consistency in safety narratives
- Conduct narrative quality control (QC) to ensure accurate and complete clinical storytelling
- Contribute to signal tracking, DSUR development, and broader safety surveillance deliverables
- Maintain regular communication with the team to align on workload and schedule, adjusting hours based on data volume and timelines
REQUIREMENTS
- PhD, PharmD, or MS in a medical or life science discipline
- 8+ years of experience in Clinical Safety or Clinical Science within clinical development (pharma or biotech)
- Proven experience leading clinical data monitoring, querying, analysis, and reporting
- Strong background in SMT prep, data interpretation, narrative review, and collaboration with medical monitors
- Prior work on large Phase III trials
- Self-starter who can operate independently at a high level in a fast-paced setting
- Excellent communicator, both written and verbal
*LI-AT1
Seniority level
Seniority level
Mid-Senior level
Employment type
Job function
Job function
Product Management and Project ManagementIndustries
Pharmaceutical Manufacturing and Biotechnology Research
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Disability insurance
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