Study Manager

Insync Staffing Inc.; Novato (CA); Hybrid; USD 89,544 - 95,054; Full time

Benefits offered by this job

Health insurance

Health savings account

Vision insurance

Flexible spending accounts

Life insurance

Job summary

A staffing agency is looking for a Sr. Study Specialist in Novato, CA. This role involves leading site monitoring and vendor management activities with responsibilities including developing study documentation and overseeing training materials. Candidates should have a BA/BS in health sciences and experience in biotechnology or pharmaceutical companies. The position offers a hybrid work model and competitive pay.

Qualifications

• Preferred: BA/BS or higher in nursing, life or health sciences.
• Experience in a biotechnology or pharmaceutical company.
• Oversight of external vendors including SOW, budgets.

Responsibilities

• Develop study‑specific documentation, as delegated by the Study Manager.
• Contribute to the oversight of country and site feasibility assessment.
• Oversight of CRO for IRB/EC related submission/approval activities.
• Manage essential documents in the Trial Master File (TMF).

Skills

Agility and Proactivity

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

Base pay range

$65.00/hr - $69.00/hr

Hybrid – 2 days per week onsite in Novato, 1‑year contract.

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:

Core Competencies

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

Responsibilities

• 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 meetings 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,

Benefits (employee contribution)

• Health insurance
• Health savings account
• Vision insurance
• Flexible spending accounts
• Life insurance

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment‑qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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