Job Title: Clinical Research Operations Manager Job Description The Clinical Research Operations Manager plays a pivotal role at the Research Institute, contributing significantly to both industry-sponsored and investigator-initiated clinical trials. This role ensures adherence to trial protocols, FDA regulations, and ICH/GCP guidelines. The Operations Manager supervises workflows, processes, clinical study coordinators, and data support teams involved in patient-facing aspects of clinical research within the department. Additionally, they provide support across various U.S. Division locations as needed. The Operations Manager collaborates closely with business development teams and Study Intake Program Managers to guarantee that all research projects are of high quality, operationally feasible, and aligned with the needs of investigators and patients. Responsibilities + Accountable for meeting accrual metrics and developing strategic measures to improve study and team performance. + Interface with Managers and leads for timely initiation and completion of clinical trials. + Collaborate with Principal Investigator (PI) to identify and address barriers in clinical studies. + Serve as the primary contact for Executive Medical Directors, Institute leaders, and Principal Investigators regarding clinical trials. + Develop scalable staffing and operational plans to extend research to various locations within network. + Manage duties for effective and compliant clinical research study coordination across multiple therapeutic areas. + Ensure the delivery of safe care with respect for all patients/participants. + Work with managers and teams to develop study budgets for research projects. + Accountable for operational review to ensure appropriate trial selection. + Collaborate with leadership to optimize workflow and scheduling for clinical operations. + Participate in task forces and meetings related to network clinical trial activities. + Work with peer leaders to resource and staff projects within the AHRI portfolio. + Provide leadership for additional research functions such as recruitment, data entry, and data management. + Guide recruitment strategies and tactics for optimal participant recruitment in Surgical and Orthopedics research. + Lead data management teams to ensure standardization and best practices. + Develop staffing plans and operational budgets consistent with institution standards. + Ensure accurate Medicare Coverage Analysis and compliant billing practices. + Create corrective and preventative action plans for safe and compliant care delivery. + Perform managerial duties related to the selection, management, and development of research staff. + Collaborate with other research departments to ensure regulatory compliance. + Establish and maintain SOPs for clinical operations and staff training. + Work with Regulatory Manager to meet compliance with regulatory agencies. + Serve as a stakeholder for committee and governance meetings. + Perform additional duties as directed by Leadership. + Monitor and direct daily research operations, reporting issues to the Executive Director of Research Operations. Essential Skills + Clinical research + Operations management + Project management + Management skills Additional Skills & Qualifications + Bachelor’s degree in medical, scientific, healthcare, business administrative, or related field + Minimum of five years’ experience + Certified Clinical Research Coordinator (CCRC) certification by the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) or Professional Certification in a clinical specialty area in the area of research focus Work Environment The role will be based onsite at all Orlando locations. Pay and Benefits The pay range for this position is $100000.00 - $130000.00 Benefits from Day One Paid Days Off from Day One Career Development Whole Person Wellbeing Resources Mental Health Resources and Support Pet Insurance* Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense) Workplace Type This is a fully onsite position in Orlando,FL. Application Deadline This position will be accepting applications until Dec 31, 2024. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.