Associate, Clinical Standards & Processes

Responsibilities

• Support study teams with eTMF set-up and maintenance.
• Manage eTMF User Access process, and facilitation of user account provisioning with IS&I department.
• Review eTMF quality metrics generated internally or from vendors.
• Ensure Vendor Issues Tracker is kept up to date.
• Manage Site Master List by overseeing site number assignment process.
• Participate in health authority inspections preparation activities.
• Absorb and prepare training refreshers for Clinical Operations staff on internal SOP/WI and other processes relevant to the department.
• Absorb and assist with development of Clinical Operations documents (forms, templates, SOPs/WIs).
• Initiate and/or participate in process improvement activities.

Requirements

• Bachelor’s Degree
• At least 2 years of experience in Clinical Operations or similar function.
• At least 1 year of experience working in eTMF system set-up and maintenance.
• Thorough understanding of all applicable FDA ICH-GCP regulations and guidelines.
• Preferred: Experience with Veeva Vault eTMF, experience with eTMF systems and TMF reference model, proficiency in MS Office (Word, Excel, and PowerPoint), strong problem-solving capabilities, exceptional organizational skills with the ability to multi-task and prioritize, attention to detail, ability to work with distributed team members and outside vendors.

Qualifications

• California pay range: $85,000 USD - $100,000

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Pay

Candidate must have current, valid authorization to work in the country where this role is located.

Schedule

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Skills

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Benefits

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