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
