Job Details

Sr. Study Specialist, Global Study Operations

Job Title: Sr. Study Specialist, Global Study Operations

Location: Hybrid 2 days/week onsite

Position Summary:

We are seeking a highly motivated Sr. Study Specialist to support global clinical study operations. In this role, you will contribute to the oversight of site monitoring, vendor management, and study execution activities that directly impact patient safety, data integrity, study quality, and timelines. You will demonstrate independence in handling complex tasks, managing vendor relationships, and supporting cross-functional study teams.

Key Responsibilities:

• Contribute to development of study documentation and training materials.


• Support country/site feasibility, site selection, and oversight of essential documents.


• Manage vendor activities, including CROs, central labs, and imaging partners.


• Oversee submissions to IRBs/ECs and ensure compliance with regulatory standards.


• Facilitate investigator meetings, including preparation and presentations.


• Ensure timely and accurate updates to study registries (e.g., ClinicalTrials.gov).


• Maintain and oversee essential documents in the Trial Master File (TMF).


• Support risk identification, mitigation, and cross-functional team meetings.


• Provide operational and administrative support across study teams.

Qualifications:

• Bachelors degree in Nursing, Life Sciences, or related field preferred (industry experience considered in lieu of degree).


• Experience in biotechnology or pharmaceuticals with hands-on oversight of vendors, budgets, SOWs, and invoice management.


• Strong knowledge of study management, compliance, and drug development processes.


• Excellent communication, collaboration, and leadership skills.

Why Join:

This is a unique opportunity to make a meaningful impact in global clinical operations, working on innovative studies that drive advances in healthcare. If you are detail-oriented, proactive, and thrive in a collaborative environment, wed love to hear from you.

Apply today to take the next step in your career as a Sr. Study Specialist!

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Science

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

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