Clinical Scientist - Safety Surveillance (PT)

Clinical Scientist - Safety Surveillance (PT)

Contract through 12/31/25 (extension possible)

Part-Time/Flex (~20 hrs/week)

REMOTE | W2 or 1099 | Can submit above published rate

Seeking a seasoned Clinical 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

location: Telecommute
job type: Contract
work hours: 9 to 5
education: Doctorate

responsibilities:
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

qualifications:
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

skills: FDA, Phase iii, GCP (Good Clinical Practice), Drug Safety, DSUR (Development Safety Update Report), ICH Regulations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.