Insight Health Systems · 3 months ago
Director of Clinical Trials Operations
Chicago, IL
Full-time
Onsite
Director/Executive
10+ years expInsight Health Systems is a physician-led organization focused on advancing excellence in healthcare and community well-being. They are seeking a Director of Clinical Trials Operations to manage and oversee clinical trials operations, ensuring smooth collaboration among cross-functional teams and adherence to regulatory standards. The role includes building infrastructure for trials, supporting research initiatives, and fostering relationships with stakeholders.
Health CareHealth DiagnosticsHospital
Responsibilities
Support the Chief Research Officer in defining and carrying forward strategic objectives at the organizational level. Provide regular updates on clinical trials, staff, key performance indicators, timelines, and deliverables
Provide oversight, management, and leadership for the Clinical Research Site Operations at Insight Chicago. Oversee all phases of clinical trials, from initial planning and site selection to study close-out
Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training
Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies
Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations
Ensure optimal recruitment strategies for the clinical trials, and implementation, and adoption of needed systems
Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects
Establish excellent relationships between widely varying stakeholders. Utilize critical thinking and problem-solving abilities to collaboratively overcome challenges and innovate solutions. Maintain diligent communication to ensure that multiple projects can be managed simultaneously and be completed on time, within scope, and within budget
Collaborate with research leadership to support budgeting, projections, business development, and financial tracking related to research operations. Ensure alignment of projects and expenditures with strategic initiatives and project, departmental and institutional goals
Propose and drive innovative improvements to procedures and operations to maximize efficiency and productivity. Participate in personnel planning and recruitment to ensure that the department has the interdisciplinary support and expertise needed to succeed
Collaborate closely with Insight Hospital personnel at all levels including cross-functional leadership, departmental/institutional shared resources, and partner/vendor organizations, to optimize efficiency, productivity and foster innovation
Overseeing relationships with principal investigators, external vendors, Sponsors, CROs, and other research-related service providers
Ensuring that all clinical trials are conducted in accordance with relevant regulations (FDA, GCP, ICH), company SOPs, and industry best practices. Review and approve applicable policies and SOPs and work closely with team members to create and improve these documents
Perform additional activities as required
Qualification
Required
10+ years of industry experience in relevant fields is required
Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials
Proficiency in MS Office including Project, PowerPoint, Word, Excel and CTMS
Excellent interpersonal communication skills
Strong analytical and reasoning skills
Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement
Ability and willingness to travel for work related trips
Preferred
Significant experience in clinical research site operations managing teams in a leadership capacity with focus on both achievement of objectives as well as critical skill-building
Prior experience in building external connections with peers, emerging technology communities and sponsors
Experience driving research objectives across areas through collaboration with internal and external stakeholders
Proven performance in earlier roles/comparable roles
Benefits
Comprehensive health, dental, and vision insurance coverage
Paid time off, including vacation, holidays, and sick leave
401K with Matching; offerings vested fully @ 3 months of employment paired with eligibility to contribute
Short & Long Disability, and Life Term insurance, complementary of Full Time Employment
Additional Supplementary coverages offered @ employee's elections: Accident, Critical Illness, Hospital Indemnity, AD&D, etc.
Company
Insight Health Systems
When it comes to treating patients and developing medical expertise for worldwide application, there is a need for tremendous insight.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ali Madha
Corporate Chief Operating Officer
Nadir Ijaz
Chief Operating Officer at Insight Surgical Hospital
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