Head Of Clinical Operations

Remote Raleigh, NC

Due to our continued growth, we are hiring for a Head of Clinical Operations at Wake Research, an M3 company. This position is hybrid and located in Raleigh, NC.

M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. M3 Wake Research is an integrated network of premier investigational sites working closely with and meeting the needs of the global biopharmaceutical, biotechnology, medical device, pharmaceutical industry, and clinical research organizations. M3 Wake Research has its proprietary patient database of potential clinical trial participants—men and women, children and adults, across all ethnicities—for all kinds of adaptive and other types of trial designs. Conducting studies since 1984, we have a combined subject database of more than 2 million.

M3 Wake Research has 23 owned and managed research sites across 9 states in the US and continues to grow. As of today, our board-certified physicians have completed more than 7,000 successful clinical trials. Clinical trials at our site are always completed on time and with accuracy; we consistently exceed sponsor expectations for integrity, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Our approach is uncompromising – each study conducted at our site is carefully planned and executed according to regulations with superior quality.

The Head of Operations will work closely with and report to the Chief Operating Officer (COO) of M3 Wake Research and will play a significant role in building the clinical research business at M3 Wake Research.

Strategic Vision and Leadership:

Provide strategic leadership including short- and long-term resource and organizational planning, and continuous improvement of operational efficiency and service offerings.
In conjunction with the Executive Team, develop, refine, and implement operational and business plans that result in annual sales and revenue as defined by the corporate blueprint.
Ensure that all projects and programs of work are executed effectively and profitably.
Interact with current clients for new business pursuits and expansion of current operations.
Lead and facilitate cross-departmental collaboration and strengthen internal communications with staff throughout the organization.
Provide leadership, mentoring and direction to staff including resourcing, capacity planning, maximizing performance, supporting compliance requirements and managing expense budgets

Operations Management:

Provide successful oversight of Operations, including the conduct of research projects, adherence to timelines and budget, evaluation of customer and employee satisfaction, provision of contracted deliverables, appropriation of qualified personnel, and administration of grants and contracts.
Corrective and risk mitigation actions are implemented as needed to maintain program performance.
Program quality reviews occur at key points with the participation of the appropriate personnel.
Fiscal requirements, projections, and budgets are developed and effectively managed.
Monthly financial forecasts are analyzed, and planned revenue/profit is within targeted ranges to maximize profitability.
Drive continuous improvement in organizational performance by keeping up to date in industry, government and global health fields; monitoring future trends; using innovative approaches, Key Performance Indicators (KPIs) and benchmarking to achieve world class clinical execution.
Represent Operations for new business opportunities and proactively participate in the proposal process.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.

Qualifications

Minimum Qualifications:

Bachelor's Degree or an equivalent combination of experience and education.
10+ years of functionally related experience.
Clinical experience in one or more therapeutic indications.
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.

Additional Information

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance

M3 reserves the right to change this job description to meet the business needs of the organization.