Overview

The Operations Manager (OM) will serve as the line manager for Clinical Trial Associates (CTA) as the team expands. This role will support the development and management of clinical operations supporting processes improvement, change management, and operational excellence. The OM will be responsible for performance management of the CTA team and ensuring access to the appropriate training, technology, and development opportunities.

Responsibilities

Line Management

* Acts as direct supervisor for CTA team

* Responsible for development of and performance management of direct reports

* Work in collaboration with the Head of Clinical Operations to identify resource needs and opportunities for efficiencies

Team Lead

* Design, implement, and manage, as necessary, study and department tools and trackers related to trial administration

* Responsible for development of clinical trial dashboards and study status Assist with change management under the direction of the Head of Clinical Operations

* May assist in the development of study team, site, and service provider (CRO) training Acts as the CTIS support for Ethics Committee submissions.

* Acts as Gov administrator

* Acts as a liaison with Regulatory and Clinical Science to triage clinical operations support needs. May represent CTA function at study team meetings, as needed

* Suggest process improvement strategies in support of trial administration support to optimize clinical trial execution

* May develop or assist in the development of training May act as a Clinical Trial Associate/ Assistant, as needed

Qualifications

* TMF experience required

* Strong knowledge of MS Word, and Excel

* Strong written and interpersonal communication skills and strong attention to detail

* The ability to work independently and as part of a team

* Must have demonstrated expertise in relevant clinical operations activities

* Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results

* Working knowledge of FDA regulations and ICH/GCP guidelines.

* Strong Computer Skills (MS Office) including the ability to format and publish large documents and create tracking systems and spreadsheets

* Aptitude to learn additional software programs and databases.

* High degree of professionalism

* Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner

Education/Experience:

* BA/BS or higher

* SoCRA or ACRP certification

* At least 3 years of clinical operations experience, 5 years or more experience Lean Six Sigma/Kaizen or other similar certification preferred