Associate Director, Clinical Operations

Piper Companies; Washington (District of Columbia); Remote; USD 140,000 - 175,000; Full time

Job summary

An established industry player is seeking an Associate Director of Clinical Operations to lead centralized monitoring efforts. This fully remote role is perfect for those with extensive experience in clinical operations, particularly in the pharmaceutical and biotechnology sectors. You will oversee key clinical activities, manage essential documentation, and ensure compliance with regulatory standards. If you have a strong background in risk-based quality management and a passion for improving clinical trial outcomes, this opportunity offers a chance to make a significant impact in the field. Join a team dedicated to advancing healthcare solutions and enjoy a comprehensive benefits package while working from the comfort of your home.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401k

Paid Time Off

Paid Holidays

Sick Leave

Qualifications

• 10+ years of experience in pharmaceutical, biotechnology, or CRO.
• Direct experience in centralized monitoring and data analytics.

Responsibilities

• Oversee clinical operations activities including project and site management.
• Manage production of regulatory and monitoring documents.

Skills

Clinical Operations

Centralized Monitoring

Project Management

Data Analytics

Risk-Based Quality Management

Job description

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.