Executive Director Of Operations
Raleigh , NC 27601
Posted 5 months ago
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M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. M3 Wake Research has more than 15 owned and managed research sites across 7 states in the US and continues to grow. Due to continued growth and expansion, we are seeking an Executive Director of Operations to oversee clinical operations and revenue acroiss our site network.
The Executive Director of Operations will work closely with the Chief Executive Officer (CEO) of M3 Wake Research and will play a significant role in building the clinical research business at M3 Wake Research.
Candidates residing in the Raleigh, NC or Southern California areas are strongly preferred, but candidates living in, or willing to relocate to, any of our site locations across the US will be considered.
Key Duties and Responsibilites:
- Develops and executes an operational strategy to achieve key business objectives.
- Builds internal regulatory processes to ensure early identification of issues relating to clinical, technical, strategic or operational information.
- 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 CEO to direct the sales team for higher value pipeline development.
- Exercises fiscal discipline and expense control.
- Partners with the CEO and other senior leaders to ensure that all site locations are equipped with strong leadership.
- Directs efforts of multiple sites as it relates to financial performance management including, but not limited to, reporting, budgeting, FTE management, compliance, strategy, clinical standards, patient and clinical work flow, scheduling protocols, hours of operation, and other business initiatives.
- Assists in setting 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.
- Develops strategies and leads the execution of site-specific plans for adoption of M3 Wake Research Inc. standards.
- 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.
- Clinical experience in one or more therapeutic indications.
- Healthcare experience in business line that delivers direct patient care and works directly with physicians.
- Bachelor's Degree in Science or Nursing required; Master's degree in Business Administration or Health Administration preferred.
- 10 years or more of functionally related experience.
- Experience with multi-site investigational site networks, SMO, TMO or hospital-owned or hospital sponsored physician networks preferred.
- 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.
- Competitive salary
- Comprehensive benefits package
- Paid time off
- Advancement and career opportunities