Executive Director, Regional Operations

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Job Summary:

This position is responsible for managing the overall business and clinical operations of the sites under their assigned responsibility to ensure that appropriate targets are met with the highest of quality. Responsible for managing the Site Directors to meet the annual and forecast operating budgets and for the efficient coordination, organization and conduct of clinical trials while ensuring the health and safety of study subjects and staff. Help identify, plan, and execute on business expansion opportunities. Will also drive the success of key operational and company initiatives, mentor and train Site Directors and ensure appropriate staffing levels to align with key business objectives.

Duties/Responsibilities:

• Works with the Senior Vice President, Clinical Operations to create, execute and proactively manage clinical trial processes. Manage the operational team to meet/exceed the company’s financial, operational and study-specific targets.
• Provide leadership, strategic oversight, and guidance of the Operations teams to ensure quality, timeline, resources and budget goals are met.
• Ensure performance indicators are in place to ensure the successful execution of clinical trials to agreed timelines.
• Help identify business expansion opportunities. Develop appropriate Business Plans to present to executive leadership and drive the execution of those plans.
• Represent all aspects of Operations and provide updates as required to the Executive Team.
• Lead and mentor Operations staff and Site Directors to support successful internal training and its implementation as serve as an advocate for professional development of Operations staff.
• Assist Head of Quality in the development, review and updating of Velocity SOPs.
• Support Head of Quality to plan and implement quality standards and provide leadership and direction to ensure compliance with Velocity SOP’s ICH-GCP guidelines and FDA regulations.
• Develop and maintain strong industry relationships to ensure effective execution of projects and support Velocity business efforts.
• Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during strategy discussions to inform planning and execution.
• Ensure timely and appropriate communications occur with staff as necessary.
• Identify and manage issues, concerns and problems related to site performance.
• Conduct business development activities on behalf of VCR with sponsors, CROs, CRAs and any third-party study vendors, as appropriate in support of the BD team.
• Share best practices with other VCR site locations with the goal of raising the overall level of operational competencies at our sites.
• Represent Velocity at industry and professional meetings
• Other duties as assigned that support the success of the overall organization.

Required Skills/Abilities:

• Expertise in project management demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow-through.
• Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decisionmaking.
• Extensive knowledge of clinical research - Understands the drug development process.
• Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project.
• Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, team members and internal relationships. Ability to conduct effective presentations.
• Computer skills - Working knowledge of MS Office suite, Clinical Conductor CTMS and relevant CRM system. Able to generate business correspondence, create forms and generate reports as required.
• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
• Ability to communicate effectively in English (both verbal and written).
• Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
• Other duties as assigned.

Education and Experience:

• Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research experience.
• 10+ years of clinical management experience or equivalent applicable experience in clinical research industry with evidence of clear leadership responsibilities.
• Expertise in project management, knowledge of field organizational strategies, extensive knowledge of clinical research, strong communication and presentation skills.

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management