The Position
The Associate, CS&P assists the Associate Director of Clinical Standards & Processes or designee with eTMF set-up and management, process improvement initiatives, and quality tasks across Clinical Operations activities.
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.
- Assist with document preparation for any internal gap assessments or audits.
- Prepare training refreshers for Clinical Operations staff on internal SOP/WI and other processes relevant to the department.
- 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.
- Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.
- Proficient in MS Office (Word, Excel, and PowerPoint).
- Ability to work in a team or independently.
- Effective interpersonal, written and verbal communication skills.
- Able to critically evaluate job tasks and the impact on overall study execution.
- Strong problem-solving capabilities.
- Effectively collaborates with Study Team members.
- Exceptional organizational skills with the ability to multi-task and prioritize.
- Attention to detail.
- Ability to work with distributed team members and outside vendors.
California pay range
$80,000-$100,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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