Senior Study Specialist

Compass Consulting

San Francisco (CA)

On-site

USD 75,768 - 89,544

Part time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

Job summary

A leading consulting firm in California is seeking a Senior Study Specialist. This role involves oversight of site monitoring and vendor management in a fast-paced environment. Candidates should have a relevant degree and experience in biotechnology or pharmaceuticals. The position offers a competitive hourly wage and is contract-based.

Qualifications

Experience in a biotechnology or pharmaceutical company.
Oversight of external vendors including SOW and budgets.

Responsibilities

Develop study specific documentation as delegated by the Study Manager.
Contribute to the oversight of country and site feasibility assessments.
Oversee CRO for IRB/EC related submission/approval activities.
Ensure accurate and timely study entry to ClinicalTrials.gov.
Oversee and manage essential documents in the Trial Master File (TMF).

Skills

Agility and Proactivity

Leadership

Communication and Collaboration

Study Management and Execution

Compliance and Quality

Drug Development and Study Design

Product and Therapeutic Area Knowledge

Education

BA/BS or higher in nursing, life or health sciences

Job description

This range is provided by Compass Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55.00/hr - $65.00/hr

Direct message the job poster from Compass Consulting

Pharmaceutical | Biotech | Quality Assurance | Recruiter Connecting Organizations With Industry Experts

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.

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:

Core Competencies:

Agility and Proactivity
Leadership
Communication and Collaboration
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge

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

Education & Experience:

BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered
Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets

Seniority level