Associate, Clinical Standards & Processes

Responsibilities:
- Support study teams with eTMF set-up and maintenance.
- Manage eTMF User Access process and facilitate user account provisioning with IS&I.
- 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.
- Participate in health authority inspections preparation activities.
- Assist with document preparation for internal gap assessments or audits.
- Prepare training refreshers for Clinical Operations staff on internal SOP/WI and relevant processes.
- 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 applicable FDA ICH-GCP regulations and guidelines.

Preferred:
- Experience with Veeva Vault eTMF.
- Experience with eTMF systems and TMF reference model.
- Proactive execution with minimal supervision.
- Proficient in MS Office (Word, Excel, PowerPoint).
- Ability to work in a team or independently.
- Effective interpersonal, written, and verbal communication.
- Strong problem-solving, organizational, and attention to detail.
- Ability to prioritize, multi-task, and work with distributed team members and outside vendors.

California pay range: $85,000 USD - $100,000 USD
Candidates must have current, valid authorization to work in the country where this role is located.