Clinical Research Regional Director

Mission of the Role:

The Regional Director works closely with the Vice President of Clinical Operations to help provide oversight and direction to Site Directors and Managers in the successful delivery of business of all assigned sites.

Essential Duties and Responsibilities:

• Manages team of Site Directors/Site Managers as assigned, providing training, mentorship and guidance to ensure success of business delivery.
• Develops and executes an operational strategy to achieve key business objectives.
• Analyzes operational and performance metrics to optimize the effectiveness and efficiency of operational teams.
• Identifies and explores ways to control cost and generate revenue.
• Works closely with the Marketing and Recruiting teams to maximize the number of patient enrollments.
• Partners with the Vice President of Clinical Operations to direct the sales team for higher value pipeline development.
• Directs efforts of multiple sites as it relates to financial performance management including, but not limited to, reporting, budgeting, FTE management, quality, strategy, clinical standards, patient and clinical workflow, protocol compliance, hours of operation, and other business initiatives.
• Assists in setting site specific financial goals that are in alignment with business strategy.
• Establishes good working relationships and collaborative arrangements with principal investigators and other leaders to help achieve the goals of the organization.
• Assists with resourcing at a site level and hiring of staff, as needed.
• Regular contact at high levels, both internal and external, where effective relationships have a significant impact on the clinical operations of the site or network as a whole.

Requirements

Requirements:

• Bachelor's Degree in Science or Nursing required or an equivalent combination of experience and education.
• 7 to 10+ years of functionally related experience.
• Clinical experience in one or more therapeutic indications.
• Previous experience as a Site Director, Site Manager or Regional Director.
• Healthcare experience in business line that delivers direct patient care and works directly with physicians.
• Strong knowledge of FDA regulations, ICH-GCP Guidelines and GCP including study management, safety management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product.
• Experience, knowledge, and commitment towards the care of patients, aspects of human subject protections, and safety in the conduct of clinical trials.
• Knowledge regarding development and regulations of drugs, devices, and biologicals.
• Data-driven and critical thinking skills to continuously improve approaches that achieve the goals as quickly as possible.
• Strong communication skills, and experience communicating within the study site as well as between the site and sponsor, CRO, and regulators.
• Ability to formulate business decisions that are financially responsible, accountable, justifiable, and defensible.

Preferred Qualifications:

• Master's degree in Business Administration or Health Administration preferred.
• Experience with multi-site investigational site networks, SMO, TMO or hospital-owned or hospital sponsored physician networks preferred.