Clinical Research Operations Lead FSM / CC

Clinical Trials Manager

This position provides clinical operational management oversight for multiple operations managers of the Cancer Center Clinical Trials Office (CTO). Manages all activities associated with biomedical and / or social-behavioral research studies considered very complex by the inclusion of several of the following : multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments / interventions; & / or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Responsible for management, administration, organization and conduct of the clinical trials operations. Oversees day-to-day operations including assigning and supervising study staff to disease teams, identifying & securing needed resources, identifying the need for process improvement and developing and implementing plans. Provides leadership, training, coaching and mentoring of clinical operation supervisors and staff. Works collaboratively with operational leaders of the CC Finance, IT and other Medical School and Hospital units and departments engaged in clinical research.

Defines and implements regulatory strategies and priorities in conjunction with Director of Research Integrity and Compliance. Ensures application of established policies and best practice regulatory standards across network regions for all filings, maintenance of existing trial registrations and agency interactions. May serve as primary regulatory contact with for FDA inspections. Assists Regulatory staff by outlining regulatory strategy and providing data needed to support filings, responses to Health Authorities inquiries, and trial registration maintenance. Oversees the regulatory workforce activities associated with highly complex biomedical and / or social-behavioral research studies including Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials. Organizes, plans, and controls work flow of the regulatory staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff.

Responsible for managing the Data Quality Assurance department to provide strategy for the oversight and quality services for oncology network trial management, CTMS electronic systems, data integrity processes, and related continuous process improvement initiatives. Provides strategic leadership in driving a consistent compliance and validation approach to policies, procedures, and standards. Performs Electronic Records / Electronic Signatures regulation and related regulation surveillance to provide guidance and instruction to the Cancer Center to ensure compliance with regulatory requirements. Anticipates and develops QA activities and processes related to electronic systems oversight based on risk. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items. Organizes, plans, and controls work flow of the QA staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff.

May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Works extensively to create and nurture collaborations and partnerships with outside affiliate institutions, nationally recognized clinical research organizations, and pharmaceutical partners.

Please note : Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and / or far-reaching implications.

Specific Responsibilities

Technical :

• Provide leadership support for clinical trials
• Manage and coordinate clinical study design and implementation at a program and functional level according to Good Clinical Practice (GCP) and Standard Operating Procedures
• Leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
• Responsible for operational input and oversight in designing, planning, initiating and completing clinical trials across assigned disease teams
• Expected to take lead in review of clinical study documents including protocols, investigator's brochures, and clinical study reports.
• Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
• Works directly with the CRO's Quality Control Manager on the development of standard operating procedures for clinical staff and also monitors compliance with procedures.
• Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution.

Administrative :

Data :

Finance :

Supervision / Training Activities :

Program Development :

Miscellaneous :

Minimum Qualifications :