Director Study Operations

McKesson•Nashville, TN

11d

About The Position

As the Director of Study Operations, you will be responsible for leading and supporting the Data Operations and Site Regulatory teams. This includes the development and execution of key strategies that support growth and execution of commitments to pharma and CRO partners. You will be responsible for departmental goals, financial performance, quality assurance, oversight, and contracted obligations. You will assist in the creation and support of internal and external Sarah Cannon strategies. You will develop, maintain, and report out performance metrics and expectations to key stakeholders on a regular basis. You will provide research oversight and direction to the management and regulatory support of all trials at the site. You will monitor data status through weekly and monthly reporting. You will manage and direct the efforts of managers and recommend colleague actions including, but not limited to, hiring, performance management, scheduling and work assignments, disciplinary action, promotions, and transfers. Define and communicate job descriptions, core competencies, performance standards, and expectations. You will establish accurate and consistent productivity expectations and revise as needed. Make recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity. Develop departmental annual goals and objectives and ensure alignment with organizational mission, vision, and values. You will build and manage strategic internal and external relationships. You will assess quality and status of study data and develop the appropriate action plans to address performance gaps. You will interact with sponsor/CRO to outline clinical and data operations and address operational needs, when necessary. You will oversee and manage day-to-day needs of site’s data and site regulatory leaders. You will develop the data operations budget, monitor expenses, and stay within budget. You will assist in the creation, development, and execution of SOPs, WI, and job aids. You will meet with the leadership team regularly to develop goals and strategies for growth, as well as evaluate progress, and keep abreast of issues and risks related to research operations. You will ensure continuing education and training to research staff. You will represent the company vision at the site. You will perform ad hoc assignments and projects for Executive leadership upon request.

Requirements

An Associate’s degree, Bachelor’s degree preferred
At least one year of leadership experience in clinical research
General knowledge of research regulatory and Quality Assurance guideline
Public presentation skills

Responsibilities

Leading and supporting the Data Operations and Site Regulatory teams.
Development and execution of key strategies that support growth and execution of commitments to pharma and CRO partners.
Responsible for departmental goals, financial performance, quality assurance, oversight and contracted obligations.
Assist in the creation and support of internal and external Sarah Cannon strategies.
Develop, maintain and report out performance metrics and expectations to key stakeholders on a regular basis.
Provide research oversight and direction to the management and regulatory support of all trials at the site.
Monitor data status through weekly and monthly reporting.
Manage and direct the efforts of managers and recommend colleague actions including, but not limited to, hiring, performance management, scheduling and work assignments, disciplinary action, promotions, and transfers.
Define and communicate job descriptions, core competencies, performance standards and expectations.
Establish accurate and consistent productivity expectations and revise as needed.
Make recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity.
Develop departmental annual goals and objectives and ensure alignment with organizational mission, vision, and values.
Build and manage strategic internal and external relationships.
Assess quality and status of study data and develops the appropriate action plans to address performance gaps.
Interact with sponsor/CRO to outline clinical and data operations and address operational needs, when necessary.
Oversee and manage day-to-day needs of site’s data and site regulatory leaders.
Develop the data operations budget, monitor expenses and stay within budget.
Assist in the creation, development and execution of SOPs, WI and job aids.
Meet with leadership team regularly to develop goals and strategies for growth as well as evaluate progress, keep abreast of issues and risks related to research operations.
Ensure continuing education and training to research staff.
Represent the company vision at the site.
Perform ad hoc assignments and projects for Executive leadership upon request.