Sr. Study Specialist, Global Study Operations

Location: San Rafael
Posted on: June 23, 2025

Job Description:

Innova Solutions has a client that is immediately hiring for an Sr. Study Specialist, Global Study Operations Position type: Full time Contract Duration: 12 months Location: San Rafael, CA (Hybrid, 2 days onsite) As a(n) Sr. Study Specialist, Global Study Operations you will: 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 Principle 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 Technical Competencies: 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 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 Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Namrata Gautam PHONE: (1) 314-523-1818 EMAIL: Namrata.Gautam@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range*: $55- $60 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: Named One of America’s Best Employers for New Grads by Forbes (2024 Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025) One of the Largest IT Staffing Firms in the US – Ranked 3 by Staffing Industry Analysts (SIA, 2024) One of the Largest Staffing Firms in the US – Ranked 13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics) Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023) One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024) AWS Advanced Tier Services Partner with 100 certifications Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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