Clinical Operations Associate Director - Remote | WFH

Job Overview

We invite applications for the role of Associate Director, Clinical Operations, a pivotal position within our Clinical Operations team. This remote opportunity is designed for an ambitious and results-driven leader who will significantly influence our clinical trials and operational strategies. You will oversee critical phases of clinical studies, ensuring compliance with regulatory standards and study protocols while facilitating informed decision-making at all organizational levels. Your leadership and collaboration with diverse teams and external partners, including Contract Research Organizations (CROs), will be essential in advancing our mission to provide impactful medicines to patients.

Key Responsibilities

• Ensure strict adherence to Good Clinical Practice (GCP) and clinical standard operating procedures (SOPs) throughout the clinical trial lifecycle.
• Oversee the successful execution of clinical studies, ensuring timely completion within the established budget.
• Lead and collaborate with a cross-functional team to effectively implement and manage clinical studies.
• Act as the primary liaison for team members and CROs, fostering productive communication.
• Develop and execute proactive clinical trial strategies, overseeing all phases of study planning and implementation.
• Review and authorize vital study documents, including protocols and informed consent forms.
• Provide consistent metrics and updates to upper management.
• Identify and address risks, challenges, and issues encountered during clinical studies, escalating when necessary.
• Assist in budgeting processes, contract negotiations, and invoice reviews.
• Manage relationships with CROs and Clinical Service Providers (CSPs), ensuring effective operational oversight.
• Potentially supervise Clinical Trial Managers (CTMs) and/or Clinical Trial Assistants (CTAs).
• Contribute to developing departmental SOPs and training materials.
• Organize and lead internal and investigator meetings as required.
  
  

Required Skills

• Proven ability to manage confidential information with integrity and discretion.
• Strategic mindset with a comprehensive understanding of departmental objectives.
• Self-motivated with strong ownership of tasks and minimal supervision.
• Excellent organizational and time management skills, demonstrating the ability to multitask in a fast-paced environment.
• Outstanding interpersonal, written, and verbal communication skills.
• Proven experience in building collaborative relationships with internal and external stakeholders.
• Capacity to thrive in a dynamic and rapidly evolving organization.
  
  

Qualifications

• A BS or BA degree in a relevant scientific or health-related field.
• A minimum of 7 years of relevant experience in the pharmaceutical or biotechnology industry, including at least 4 years in a study oversight capacity.
• In-depth knowledge of FDA and EMA regulations, ICH guidelines, and GCP standards for conducting clinical studies.
• Demonstrated experience managing CROs and external vendors, with a focus on financial management.
• Strong understanding of financial aspects of clinical studies, including CRO contracting and budget approval processes.
• Proficiency in MS Office Suite (Outlook, Word, Excel, PowerPoint), with MS Project experience considered a plus.
  
  

Career Growth Opportunities

This role provides a unique chance for professional advancement within a leading organization known for its dedication to innovation in healthcare. You will have opportunities to take on leadership responsibilities and collaborate across various teams, contributing to the strategic direction of clinical operations.

Company Culture And Values

We are an equal opportunity employer committed to fostering a diverse and inclusive workplace. Our culture emphasizes collaboration, integrity, and a relentless pursuit of excellence in advancing healthcare solutions.

Compensation And Benefits

• Competitive compensation package with comprehensive healthcare coverage (medical, dental, and vision).
• Fully funded Healthcare Savings Account for high-deductible PPO Plan.
• 4 weeks of paid time off annually, in addition to 10 company-paid holidays and a year-end shutdown.
• 401(k) plan with company match, offering traditional and Roth options.
• Life insurance, short-term and long-term disability coverage, and other paid benefits.
• Flexible spending accounts for medical and dependent care expenses.
  
  

Employment Type: Full-Time