Associate Director, Clinical Operations - Centralized Monitoring

Job Title

Associate Director, Clinical Operations - Centralized Monitoring

Location

Bethesda, MD 20817 US (Primary)

Category

Clinical Operations

Job Type

Full-Time

Salary Range

135,000.00-175,000.00/YEAR

Education

Bachelor's Degree

Travel

None

Job Description

• Establish risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials.
• Review protocols to ensure the set-up, review, and reporting requirements for KRIs and QTLs can be met and are standardized.
• Provide leadership, technical oversight, guidance/training, and coordination for all central monitoring activities.
• Serve as hiring manager and line manager to central monitors.
• Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions.
• Serve as Central Monitoring Subject Matter Expert (SME) while directing cross-functional teams during the development, implementation, and execution of central monitoring dashboards.
• Advise clients and study sponsors on industry-standard best practices for conducting centralized monitoring and serve as escalation point for client and internal teams.
• Collaborate and assist with oversight of other clinical operations activities, such as clinical site monitoring.
• Applies a thorough understanding of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and statistical requirements in the conduct of central monitoring.
• Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse.
• Responsible for resource management, tracking, and allocation, including level of effort projections, and managing deliverables within budget and to well-defined timelines.
• Effectively communicates in a matrix management organization and can represent the clinical team during cross-functional collaboration.
• Collaborates with Director and other departments and leads on clinical operations strategy and vision to support clinical trial activities and central monitoring activities.
• Informs division leadership on the overall status of clinical programs/projects and of potential issues/mitigation.
• Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays.
• Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
• Support and comply with the company’s Quality Management System policies and procedures.
• Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development, participation in proposal writing, budget development, and bid defense meetings.
• Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up.

   

Job Requirements

• Depth of knowledge and experience conducting centralized monitoring in a CRO setting across various clinical trials.
• Experience managing/directing central monitoring teams, writing procedures, and advising on central monitoring best practices and tools.   
• Able to mentor staff and achieve high quality performance through risk management/ mitigation and implementation of corrective/ preventive actions, as needed. 
• Strong facilitation, presentation, problem-solving, and conflict resolution skills; including ability to keep up with changing priorities, seasoned oral and written communications skills, strong attention to detail with ability to QC information, and experience in the use and development of clinical research databases/ systems/ tools.
• Strong leadership skills including change management, people development, strategic thinking, and influencing.
• Advanced ability to manage team resources to ensure attainment of department objectives.
• Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project.
• Proposal writing and bid defense skills is a plus.
• Prior experience as a CRA conducting site monitoring is a plus.
• Background in Infectious Disease/HIV clinical trials and/or Oncology; or prior work on a government contract, is a plus.
• This position is remote and open to candidates based in the following states: Maryland, Washington Dc, Virginia, North Carolina, Georgia, Florida, and Texas.

 

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.