IGM Clinical Research Operations Manager

Overview:

Job Description Summary:

(not specified)

Job Description:

The Clinical Research Operations Manager provides operational and administrative oversight and is responsible for planning, developing, and implementing strategic plans aimed at both the operational and administrative components of research projects within the Institute for Genomic Medicine (IGM). The Clinical Research Operations Manager will evaluate and manage the implementation and operations of directives, including compliance and fiscal impact, and will partner with various individuals throughout IGM including, but not limited to the IGM Executives, Directors, Principal Investigators to expeditiously implement such directives.

Essential Functions:

Project Leadership

• Provide administrative support to project leadership as needed, including scheduling meetings and teleconferences, developing agendas and meeting materials, coordination of meeting/call speakers and preparatory materials, circulating meeting minutes, and proactively tracking status of action items through completion.
• Assist project leadership with reporting of study results; assist project leadership and PIs with manuscript and presentation preparation.
• Assist project leadership with the tracking and reporting of study progress, milestones, and enrollments.
• Lead and execute clinical research studies and programs for IGM.
• Lead the troubleshooting process to reach resolutions for any issues that arise during the course of a project.
• Identify and develop project plans which detail the begin/end dates, tasks, resources, milestones, and expectations of all selected project resources.
• Create and maintain project documentation as appropriate for every project assigned and launched.
• Maintain knowledge of appropriate project management tools.
• Identify growth and optimization opportunities and design execution roadmaps.
• Ensure compliance with IRB and other relevant guidelines during protocol development and throughout study operations.

Workflow Management

• Collaborate with partners to strategize and execute sample management plans, ensuring the development and support of necessary infrastructure.
• Assist in defining and developing clinical research strategy and study protocols.
• Audit operations to ensure compliance with protocol and applicable regulations and implement corrective action plans as needed
• Create, document, and ensure adherence to policies and Standard Operating Procedures (SOPs) for clinical research operations.
• Design and/or restructure operating models, organizational structures, and service delivery models as they related to clinical research functions within IGM.
• Oversee and manage complex, cross-functional execution of key strategic projects and see them through to completion with internal and external stakeholders as necessary.
• Ensure progress and alignment of efforts across different teams, identify and resolve bottlenecks.
• Maintains an issues list and manages the deliverables and resolution of those issues in an effective and timely manner; using judgment in escalating of issues when appropriate.

Business Operations & Employee Management

• Develop performance goals and objectives to ensure accuracy, quality and customer expectations are met.
• Accountable for department key performance indicators, metrics and strategic goals.
• Direct and oversee job assignments and plan daily, weekly, monthly goals.
• Achieve financial plans and budget objectives as needed by the IGM Administrative Director.
• Develop business plans with multi-disciplinary groups within and outside of IGM. Potential projects would include improvement of tissue and clinical data acquisition and processes, including tissue and data flow, as well as data optimization, and implementation of new/expanded project guidelines.
• Designs, develops and maintains planning analyses and reports, including presentations and special projects within IGM. This includes but is not limited to, animal studies, new biospecimen and clinical data processing pipelines, and expansion into additional IGM genomic initiatives.
• Performs research and develops analyses of IGM projects and achievements/progress, for local, national, and international IGM -related endeavors, creating assessments of protocol and/or best practice and opportunities for project collaboration and/or expansion.
• Manage clinical research staff including providing work direction and annual reviews. Recruit, train, evaluate, develop, and as necessary, discipline and/or terminate subordinate staff. Assures that performance standards for all staff are met. Ensures the orientation of section personnel to role functions, policies and procedures and information systems. Assists and directs staff in the identification of their own learning needs and assists staff in meeting those needs.
• Lead, guide and direct associates to meet or exceed operational goals, as well as monitoring performance, providing coaching, counseling, and development; and use Key Performance Indicators to make ongoing improvements and enhancements.

Communications and Collaborative Interactions

• Communicate with leadership and clinical/data teams to develop execution strategies for sample flow and management, bioinformatics needs, and general day to day issues.
• Serve as a liaison with clinical research professionals throughout NCH, the Institutional Review Board, and with external institutions.
• Direct and ensure top service for internal/external customers.
• Assists Directors/PI’s and Supervisors with project needs, demand for services, capacity, etc. for short and long-range strategic, programmatic and facility plans and processes. This includes direct meetings with external and internal groups, including but not limited to Sponsors, contracting companies, IGM leadership, IGM staff, NCH research collaborators, etc.
• Serves as a point of contact and manager between IGM leadership, pathologists, technicians, and other NCH stakeholders.
• Discusses on a regular basis with other supervisors, Managers, and Clinical Directors to review status of research/clinical cases and recommends alternative strategies when appropriate.

Education Requirement:

Master’s degree in a healthcare related field

Skills:

• Impeccable verbal and written communication skills with the ability to distill complex issues and translate them into concrete action plans
• Exceptional leadership and management skills
• Demonstrated presentation skills. Demonstrated skill in oral and written communication. 
• Establishes metrics and means for evaluation of the program; contributes to progress reports to Research and external leadership.

Experience:

• 8+ years of operating experience including scaling teams, leading business units, project management, and a track record of exceeding KPIs
• Experience in scaling and leading large teams

Physical Requirements:

Note frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit.

• Sitting – Frequently 
• Stooping – Occasionally 
• Standing – Frequently 
• Talking on the phone or in person – Constantly
• Walking – Frequently 
• Operating a computer and typing – Constantly

Additional Physical Requirements performed but not listed above:

(not specified)

Business Analytics – Working Knowledge (Meets Expectations), Emotional Intelligence – Extensive Experience (Meets Expectations), NCH Core Values – Basic Understanding (Meets Expectations), Organizational Savvy and Politics – Extensive Experience (Meets Expectations), Self-Directed Growth and Development – Extensive Experience (Meets Expectations), Workforce Diversity Management – Extensive Experience (Meets Expectations)

“The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet”

Read Full Description