Arrowhead Pharmaceuticals
Associate, TMF Operations
San Diego, California, United States
Sponsorship not specified$70k-$100kDetected 5 days ago
GCPExcelProcess ImprovementFDA RegulatoryResearchAnimal StudiesCommunicationProblem SolvingOrganizational SkillsMicrosoft Office
About the role
- The Associate, TMF Operations assists the Associate Director of TMF Operations 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.
- Manage Site Master List by overseeing site number assignment process.
- Assist with document preparation for any internal gap assessments or audits.
- Assist with development of Clinical Operations documents (forms, templates, SOPs/WIs).
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.
- Experience with Veeva Vault eTMF.
- Experience with eTMF systems and TMF reference model.
- Ability to work in a team or independently.
- Exceptional organizational skills with the ability to multi-task and prioritize.
- Ability to work with distributed team members and outside vendors.
- Candidates must have current, valid authorization to work in the country where this role is located.
Skills
- Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
- Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Compensation
- California pay range
Benefits
- Participate in health authority inspections preparation activities.
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This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.