Director/Manager of Clinical Operations

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Our client is looking for a Director or Manager of Clinical Operations to oversee multiple trials simultaneously at multiple sites. The qualified candidate will oversee all clinical operations activities, partnering with team colleagues, contributing to the overall strategic direction and vision of the clinical development function.

Responsibilities include but are not limited to:

 • Manage all Clinical Operations functions for multiple studies across multiple sites

 • Manage CRO’s and other vendors ensuring the completion of work according to agreed timelines

• Manage and oversee key operational functions of internal Project Teams, while ensuring external contract organizations are in sync with trial objectives and parameters

• Make appropriate budgetary allocations to targeted opportunities

• Evaluate appropriateness of requests for increased budgets

• Direct the use of financial standards across work teams for consistent level of compliance

• Actively lead and create successful strategies for patient recruitment and trial site selection

• Provide technical/content expertise to lead teams and complex studies within the Clinical Operations group
• Direct the adherence to ICH/GCP guidelines, local regulatory requirements and SOPs/SWPs

• Review 3rd party work product and deliverables to approve payment of invoices and resolve discrepancies
• Support the activities of development from a portfolio perspective and review quality of data from studies prior to submission
• Proactively assess risks and develop and implement creative solutions, facilitating across teams to identify clinical operations issues and proposing solutions
• Comprehensively assess options to address study issues, align business and clinical operations objectives across multiple CROs, project teams and departments
• Support the execution of clinical operations strategies and implementation of new processes and systems
• Manage new tools and resources (tools, systems, vendors, etc.) while minimizing their costs to the organization
• Setting key deadlines and project milestones for projects
• Comply with all applicable laws/regulations of each country in which we do business
• Lead vendor selection activities for multiple clinical studies, including RFI, RFP, budget review and negotiation, assessment of vendor’s capabilities
• Manage vendor performance and budget
• Provide operational expertise for initiating, enrolling, managing and closing-out clinical studies at all phases
• Contribute to the development and writing of protocols, IBs, and other regulatory documents. Interact with regulatory, medical and statistical consultants in support of the clinical development plan
• Act as liaison for Program Teams

Qualifications/Desired Experience: - BS/MS in relevant field - A minimum of 5 years clinical operations experience - Must be able to substantiate successful experience across all phases of clinical trials (I - III). - Ophthalmology experience is highly desirable but not required.

RESPONSIBILITIES: 

• Candidates will work with fellow scientists to designing and executing experiments including small-scale studies, and pilot plant and manufacturing studies in a variety of types and scales of equipment from bench top to pilot-scale, and, as required, technology transfer and validation in commercial plants. 

• Based on the analyses of these studies, these positions will be expected to develop and test new hypotheses to improve fundamental understanding of the chemical and biochemical processes, including bio-conjugation or large and small molecule combinations. 

• This position will support process validation, quality by design, regulatory approaches, and quality systems 

• This position requires a highly motivated individual with the ability to work closely with other members of the laboratory and the department in a matrix environment. 

• This position will also collaborate with the pilot plan and manufacturing staff on experimental studies, clinical manufacturing, and process validation, including work with external contract manufacturing organizations