Job Description

Sr. Study Specialist – Global Study Operations

Location: San Rafael, CA (Hybrid – 2-3x on-site)

12-month W2 Assignment

Pay: $58-$60/HR

Our client, a global pharmaceutical company focusing on developing gene therapeutics for patients with rare genetic diseases, is seeking a Sr. Study Specialist to join their team. You will play a key role in clinical trials by supporting study planning, execution, and oversight in collaboration with internal stakeholders and external vendors. This position provides operational support for clinical study activities and leads critical tasks that impact study timelines, data quality, compliance, and patient safety.

Reporting to the Study Manager or Program Lead (PL), the Sr. Study Specialist operates with a high degree of independence, managing complex vendors, clinical sites, and escalation issues. The ideal candidate will bring strong experience in global clinical trial execution within a biotech or pharmaceutical environment.

Key Responsibilities:

• Develop and maintain study-specific documentation as delegated by the Study Manager
• Contribute to feasibility assessments, site selection, and site activation planning
• Oversee CRO submission/approval activities for IRB/EC processes
• Manage and track essential documents throughout the study lifecycle
• Develop and deliver investigator training materials and present at investigator meetings as needed
• Ensure accuracy and compliance with ClinicalTrials.gov registration and updates
• Process documentation for signature via DocuSign and facilitate Screening Authorization Forms
• Oversee clinical trial insurance requirements and tracking
• Represent Global Study Operations (GSO) in cross-functional meetings, take minutes, and provide administrative support
• Oversee and manage TMF content and document quality
• Identify study risks and support mitigation planning
• Collaborate effectively with internal stakeholders and vendors to ensure study progress and alignment with timelines and budgets

Required Skills & Qualifications:

• Bachelor’s degree (BA/BS) or higher in Nursing, Life Sciences, Health Sciences, or a related field preferred
• Equivalent industry experience may be considered in lieu of a formal degree
• Prior experience in biotechnology or pharmaceutical clinical operations
• Proficiency with vendor oversight, SOWs, budgets, purchase orders, and invoice management (CROs, central labs, imaging vendors, etc.)
• Strong understanding of drug development processes and study design principles
• Experience with essential document management, ClinicalTrials.gov submissions, and GCP compliance

Please submit your resume in Word or PDF format to be considered.

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