Senior Associate, Clinical Standards & Processes

The Position

The Senior 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.

* Assist Senior Manager with eTMF and study TMF training for internal and external access.

* Participate in eTMF user access process for CS&P in accordance to applicable SOP/WI.

* Manage assignment and tracking of Veeva Vault study licenses.

* Perform oversight to Third Party TMF Vendor and Veeva Vault eTMF System.

* Provide sponsor oversight to eTMF quality metrics generated internally or from vendors.

* Participate in review of SOPs and WIs during annual reviews or as needed.

* 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, Job Aids, Training Materials).

* Initiate and/or participate in process improvement activities.

Requirements

* Bachelor's Degree

* At least 3 years of experience in Clinical Operations or similar function.

* At least 2 years of technical experience working in eTMF system set-up and maintenance.

* Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines.

* Thorough understanding of TMF standards and reference model.

Preferred

* Experience with Veeva Vault eTMF.

* Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.

* Proficient in MS Office (Word, Excel, and PowerPoint).

* Proficient in Smartsheets.

* 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