Compliance Operations Manager

Job Description

The Compliance Operations Manager will be based in our downtown location. This position provides clinical operational management oversight for multiple operations managers of the Cancer Center Clinical Trials Office (CTO). The role involves managing all activities associated with complex biomedical and social-behavioral research studies, ensuring completion of contract requirements and client specifications. The manager will oversee day-to-day operations, assign and supervise study staff, secure needed resources, and identify and implement process improvements. Additionally, the manager will provide leadership, training, coaching, and mentoring to clinical operation supervisors and staff, and work collaboratively with operational leaders from various departments.

ResponsibilitiesProvide clinical operational management oversight for multiple operations managers.Manage all activities associated with complex biomedical and social-behavioral research studies.Ensure completion of contract requirements and client specifications.Oversee day-to-day operations, including assigning and supervising study staff.Identify and secure needed resources for clinical trials.Develop and implement process improvement plans.Provide leadership, training, coaching, and mentoring to clinical operation supervisors and staff.Work collaboratively with operational leaders from various departments.Define and implement regulatory strategies and priorities in conjunction with the Director of Research Integrity and Compliance.Ensure application of established policies and best practice regulatory standards across network regions.Serve as the primary regulatory contact for FDA inspections.Provide data needed to support filings and responses to Health Authorities inquiries.Oversee the regulatory workforce activities associated with complex research studies.Organize, plan, and control workflow of the regulatory staff.Ensure clinical trials are conducted in compliance with federal, state, and institutional guidelines.Develop SOPs and training programs for clinical staff.Manage the Data Quality Assurance department to provide oversight and quality services for oncology network trial management.Provide strategic leadership in driving a consistent compliance and validation approach to policies, procedures, and standards.Develop QA activities and processes related to electronic systems oversight based on risk.Develop staff to serve as QA representatives on project teams.Ensure completion of quality-related action items.Collaborate with outside affiliate institutions, clinical research organizations, and pharmaceutical partners.Essential SkillsMinimum 5-7 years of experience in regulatory and quality assurance.Experience in clinical research, oncology, and managing clinical trials.Knowledge of Good Clinical Practices (GCP) and federal, state, and institutional guidelines.Strong leadership, training, coaching, and mentoring skills.Ability to manage complex biomedical and social-behavioral research studies.Experience with electronic systems oversight and data integrity processes.Strong organizational and planning skills.Additional Skills & QualificationsManagement experience is a plus.Experience in multi-site studies and industry-based studies.Familiarity with audit, adverse event reporting, and clinical documentation.Experience with clinical data, monitoring tools, patient recruitment, and regulatory requirements.Ability to develop SOPs and training programs.Work Environment

This role is based in our downtown location, requiring five days a week during training, and allowing for one day of remote work after six months. The team structure includes a Director of Oncology, Clinical Research Managers, Project Managers, CRC Leads, CRCs, and Data Coordinators. The team consists of roughly 60 CRCs divided into different subspecialties, 10 Data Coordinators, and 15 Regulatory staff members. The company offers meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts, and comprehensive programs and services to help employees and their families navigate life's challenges and opportunities.

Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information.

Pay and Benefits

The pay range for this position is $48.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Chicago,IL.

Application Deadline

This position is anticipated to close on Mar 12, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.