Clinical Operations Analyst - Onsite (Exp in Manufacturing Industry)

MillenniumSoft Inc; Irvine (CA); On-site; USD 41,000 - 58,000; Full time

Job summary

MillenniumSoft Inc in Irvine, CA seeks a self-motivated Clinical Operations Analyst to support clinical study activities, including contract management, inventory, device procurement, and data entry, ensuring compliance with SOPs. You will track study progress, generate reports, coordinate with site staff and investigators, manage payments and invoices, and help maintain study documentation.

Strong communication between clinical and engineering teams is essential, with attention to detail and

Qualifications

• Proficient with MS Office Suite (Word/Excel/PowerPoint/Outlook/Teams).
• Good understanding of contractual terms is desirable.
• Familiar with Medical, Pharmaceutical or Clinical Research industry.
• Ability to work with cross-functional teams.

Responsibilities

• Support study plans, contracts, and other study related materials to assure quality, compliance, and organization of all assigned study projects
• Prepare, document and support Master service contracts and Statement of work for different studies
• Processing PO's and Invoices, Site payment monitoring and tracking
• Conduct site budget payment reconciliations to validate the accuracy of payments made against approved budgets, identify and resolve discrepancies, and ensure alignment with contractual terms and financial records
• Effectively work and communicate with investigator, site staff and internal project teams
• Order BD equipment for studies, managing inventory and shipments to study sites
• Follows SOP to ensure device accountability
• Support Site and Sponsor communications along with all study related documentation
• Attend meetings and document discussions
• Track and maintain all Clinical study related documents
• Support data analysis using MS Excel and organize reports of data

Skills

Communication

Self-motivation

Tools

MS Office Suite

Job description

Job Title

Clinical Operations Analyst

Job Location

Irvine, California

Duration

12 Months

Job Description

We are seeking a self-motivated Clinical Operations Analyst to join our growing team in R&D. The Clinical Operations Analyst is responsible for supporting clinical study activities which includes managing clinical operations, including payment processing, contract management, inventory management, device procurement, shipping, and data entry. The Analyst will support with tracking study progress, and generating reports which includes interacting and communicating with site staff and key study personnel. This position will ensure that all activities will be conducted in accordance with regulations and standard operating procedures.

Pay rate

$35/hr

Responsibilities

• Support study plans, contracts, and other study related materials to assure quality, compliance, and organization of all assigned study projects
• Prepare, document and support Master service contracts and Statement of work for different studies
• Processing PO's and Invoices, Site payment monitoring and tracking
• Conduct site budget payment reconciliations to validate the accuracy of payments made against approved budgets, identify and resolve discrepancies, and ensure alignment with contractual terms and financial records
• Effectively work and communicate with investigator, site staff and internal project teams
• Order BD equipment for studies, managing inventory and shipments to study sites
• Follows SOP to ensure device accountability
• Support Site and Sponsor communications along with all study related documentation
• Attend meetings and document discussions
• Track and maintain all Clinical study related documents
• Support data analysis using MS Excel and organize reports of data

A strong clinical and engineering communication skill set is needed to facilitate working with client and clinical site teams.

Must be a highly motivated self-starter who is able to achieve results with minimal direction. Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills. Must be proactive and provide attention to details.

Qualifications

• Must be proficient with Microsoft Office Suite (Word, Excel, Power Point, Outlook, Teams)
• Good understanding of contractual terms
• Familiar with Medical, Pharmaceutical or Clinical Research industry
• Ability to work with cross-functional teams