Skip to main content

Search Jobs

Find your next opportunity today.

Sr. Study Specialist, Global Study Operations

San Rafael, CA 94901

Posted: 06/11/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12188 Pay Rate: $60.00 - $62.00 Remote Friendly: Hybrid

Job Description

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Overview:
  • The Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets.
  • The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Role Summary:
  • The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL).
  • This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget.
  • The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
  • Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies.

Responsibilities include but are not limited to:
  • Develop study specific documentation, as delegated by the Study Manager
  • Contribute to the oversight of country and site feasibility assessment and site selection.
  • Oversight of CRO for IRB/EC related submission/approval activities
  • Oversight of essential documents for study life-cycle management
  • Develop/Oversee site and investigator training materials
  • Present at investigator meetings as assigned
  • Ensure accurate and timely study entry and updates to ClinicalTrials.gov
  • Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
  • Process documents for signature in DocuSign
  • Oversight of Clinical Trial Insurance
  • Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
  • Oversee and manage essential documents in the Trial Master File (TMF)
  • Contribute to Global Study Operations risks identification and mitigations.
  • Provide support and administrative assistance with internal and external meetings

Job Requirements

Core Competencies:
  • Agility and Proactivity
  • Leadership
  • Communication and Collaboration

Technical Competencies:
  • Study Management and Execution
  • Compliance and Quality
  • Drug Development and Study Design
  • Product and Therapeutic Area Knowledge

Skills:
  • Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)

Education:
  • BA/BS or higher in nursing, life or health sciences is preferred.  Industry or relevant experience in lieu of education is considered.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!