Associate Director Clinical Operations - Centralized Monitoring

Remote (Must be based in MD, NC, VA, DC)

$135,000-$175,000

Job Description

EPM is partnered with a leading Contract Research Organization (CRO) dedicated to advancing clinical research and improving patient outcomes. Our partner is renowned for its innovative approach, cutting-edge technology, and commitment to excellence in clinical trials. With a global presence and a diverse portfolio of therapeutic areas, they offer a dynamic and collaborative environment for professionals passionate about making a difference in healthcare. Join a team that values integrity, innovation, and impact, and be part of a mission to transform clinical research.

Key Qualifications

• Bachelor's degree in Life Sciences, Nursing, or a related field; advanced degree preferred.
• Minimum of 8 years of experience in clinical operations, with at least 3 years in a leadership role.
• Proven experience in central monitoring and remote data review.
• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Excellent leadership, communication, and interpersonal skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Experience with budget management and resource allocation.
• Proficiency in clinical trial management systems (CTMS) and other relevant software.

Key Responsibilities:

• Oversee the planning, execution, and management of clinical trials.
• Lead and mentor a team of clinical operations professionals.
• Ensure compliance with GCP, regulatory requirements, and company SOPs.
• Collaborate with cross-functional teams to achieve project goals.
• Manage budgets, timelines, and resources effectively.

• Build and develop a team of CTM's and CRA's to monitor clinical trials

• Establish Risk-Based Quality Management and Centralized Monitoring processes 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 technical oversight, guidance and coordination for all the central monitor activities.
• Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions.

Benefits

• Medical
• Dental
• Vision
• PTO