Associate Director, Regional Clinical Operations (RECO) - Central US REMOTE

Advanced Clinical - Wilmington, DE

Full-time - Mid Level

Remote - Wilmington, DE

Administrative and Support Services

About the position

The Associate Director, Regional Clinical Operations (RECO) is a key leadership role responsible for overseeing the operational delivery of clinical trials in the central US. This position involves strategic planning, management of local Clinical Research Associates (CRAs), and ensuring compliance with quality standards. The RECO will work closely with various stakeholders to enhance recruitment efforts, particularly focusing on underrepresented populations in clinical trials, and will play a crucial role in aligning local and global operational goals.

Responsibilities

• Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan.
• Accountable for planning and executing assigned country study goals and commitments, leading and participating in regional and/or local meetings and training sessions.
• Develops and maintains relationships with key institutions and stakeholders to support clinical trial recruitment.
• Drives the identification and inclusion of sites that can enroll historically underrepresented populations in clinical trials.
• Oversees regional study feasibility, site monitoring performance, and quality metrics for assigned studies.
• Provides support and training for sites to enhance diverse recruitment and retention efforts.
• Collaborates cross-functionally to build strong relationships that contribute to key study activities and milestones.
• Communicates regularly on country study status and escalates unresolved issues appropriately.
• Collaborates with the Global Study Team to develop and execute local risk management plans.
• Ensures timely submission of all regulatory, IRB, and administrative submissions for in-house studies.
• Maintains oversight and ensures consistency across studies and alignment across CROs for outsourced studies.

Requirements

• 5-7 years of experience in Clinical Trial Operations in the pharmaceutical/biotechnology industry or Clinical Research Organization, including at least 3 years in a role of primary responsibility for clinical trial execution and management.
• Minimum of Bachelor's Degree in science or a related discipline required.
• Thorough understanding and experience in global clinical trials with diverse patient populations, preferably in oncology and/or IAI.
• Direct management experience and supervisory responsibility.
• Demonstrated leadership and management skills.
• Excellent interpersonal, organizational, problem-solving, and communication skills.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with timelines and quality standards.
• Proficient in Outlook, Word, Excel, and PowerPoint.

Nice-to-haves

• Experience working with external specialist vendors.
• Strong communication skills, particularly in regulatory guidelines and clinical terminology.
• Ability to work independently and collaboratively within a team.
• Problem-solving skills to diagnose inefficiencies and recommend solutions.

Benefits

• Remote work flexibility
• Competitive salary
• Professional development opportunities
• Health insurance coverage
• 401k retirement plan