Associate Director, Clinical Operations

Piper Health & Sciences is actively seeking an Associate Director of Clinical Operations with a high emphasis on centralized monitoring for an opening with a CRO in the Washington, DC area. (Please note: this role is fully remote for candidates who reside in DC, MD, VA, NC, FL, TX, or GA.)

Responsibilities for the Associate Director, Clinical Operations include:

1. Oversee clinical operations activities including project management, site management, and clinical systems management.
2. Manage production of essential regulatory, study start-up, and site monitoring documents.
3. Responsible for multiple government or commercial contracts in several therapeutic areas, primarily infectious disease, oncology, vaccines, and medical device.
4. Establish Risk-Based Quality Management and Centralized Monitoring processes and protocols.
5. Provide technical oversight and guidance for centralized monitoring activities, review system outputs, and make recommendations for corrective actions as needed.
6. Perform risk-based quality reviews and monitor KPIs as required by external clients.
7. Collaborate with Director and other clinical departments to lead operational strategies and support clinical trial activities.
8. Ensure accurate, proper documentation of processes within projected timelines.

Qualifications for the Associate Director, Clinical Operations include:

1. 10+ years of pharmaceutical, biotechnology, and/or Clinical Research Organization (CRO) experience is required.
2. Direct centralized monitoring experience (particularly data analytics/risk-based quality management) is required.
3. Hands-on experience with clinical operations, site monitoring, or clinical project management.
4. Experience with Phase 1 clinical trials protocols, especially related to Infectious Disease/Oncology, is strongly preferred.

Compensation for the Associate Director, Clinical Operations includes:

1. Salary range: approximately $140,000 - $175,000 annually, commensurate with experience.
2. Comprehensive Benefits: Medical, Dental, Vision, 401k, remote/hybrid schedule, PTO, Paid Holidays, sick leave as required by law.

This job opens for applications on 1/21/2025. Applications will be accepted at least 30 days after the posting date.