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About the Role

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.

Responsibilities

Plan, implement, facilitate, and evaluate the full execution of assigned clinical trials.
Oversee management of multiple clinical trials from planning to analysis phase for client delivery.
Ensure operational aspects of functional areas comply with ICH guidelines, GCP, applicable regulatory guidelines, and trial procedures.
Ensure assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) coordinate the organization and implementation of a clinical trial and manage activities between functional areas and the client.
Serve as primary senior interface on the project with CTI executive management and the sponsor.
Provide effective client management to prevent and mitigate trial issues.
Escalate identified trial, staff, or CTI issues to executive management as needed.
Actively participate in resolution activities.
Oversee preparation of all study plans and project timelines and monitor against project progress.
Ensure project activity compliance with plans and suggest/implement alternative solutions to problems with timelines, schedules, resources, budgets, etc.
Take corrective action where necessary.
Assess resource needs with functional area managers and establish appropriate project team in conjunction with assigned CPM.
Monitor ongoing resource needs for the project.
Ensure appropriate project management tools are used to track and report project progress and metrics.
Ensure timely entry of project information by all team members.
Ensure training of assigned project teams.
Participate in staff training for projects, dependent upon expertise.
Oversee the management of budgeted hours by CPMs, who evaluate and manage regional project budget against project milestones.
Ensure CPMs take corrective measures to keep projects in line with budget expectations.
Ensure CPM assesses scope of work against client contractual agreements and assist in changes of scope orders.
Provide review of changes in scope notifications and work with Business Operations to ensure completion of needed contract amendments.
Synthesize and analyze new information against past experience, project information related to trial milestones in contracts, and sponsor expectations to develop strategies for effective problem-solving and project advancement.
Keep CTI executive management and the client informed.
Ensure CPM initiates corrective action.
Conduct or attend trial team and sponsor meetings.
Ensure agendas and minutes are effectively prepared to facilitate trial communication and documentation of trial oversight, discussions, and decisions.
Review weekly and/or monthly project status reports prior to forwarding to client and assure their quality, as well as all other sponsor deliverables.
Report project progress, issues, and scope of work considerations to executive management.
Provide input for new business development (NBD) proposals, assist in project budget preparation/review, and represent project management services during NBD client presentations.
Participate in new business recruitment and marketing activities.
Seek NBD opportunities when appropriate and communicate these opportunities to Business Development.
Provide supervision, guidance, and mentoring to CPMs while encouraging independence and refinement of CPM skills.
Foster professional development of CPC staff.
Review and assess internal and external quality assurance reports for assigned projects and ensure corrective action as necessary by the project management team.
Provide leadership in process improvement activities and initiatives.
Provide leadership and share expertise with clinical operations staff.
Facilitate the development of reference and resource materials for CPMs and clinical operations.
Participate in staff training and development activities.

Requirements

Fully eligible to live and work in the country of application.
Excellent verbal and written communication skills.
Ability to foster strong customer service and collegial relationships with clients, peers, and other internal and external customers and promotes this in others.
Demonstrates effective interpersonal and positive leadership skills.
Excellent organizational, record retention, and time management skills.
Excellent decision-making and creative problem-solving skills.
Demonstrated critical thinking skills and ability to effectively manage shifting priorities.
Demonstrated strong knowledge and clear understanding of CTI SOPs.
Demonstrated ability to effectively manage conflict and provide leadership in facilitating problem-solving by offering solutions.
Proficient with technology and software systems.
Ability to understand, interpret, and explain complex medical details.
Ability to lead and foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goals.
Demonstrated extensive knowledge and clear understanding of the overall drug development process and medical/pharmaceutical terminology.
Demonstrated expertise in ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
Demonstrated extensive knowledge of global regulatory requirements related to trial management in assigned geographical regions.
Ability to effectively manage client relations to enable achievement of their program's goals.
10 years of clinical research experience and/or experience in clinical project management demonstrating a clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas.
Experience in management of clinical trials.

Skills

Clinical trial management
ICH guidelines
Good Clinical Practices (GCP)
Regulatory guidelines
Project management
Client management
Problem-solving
Resource assessment
Project tracking
Reporting
Staff training
Budget management
Scope of work assessment
Contract analysis
Process improvement
Leadership
Mentoring

Location

Greater Cincinnati, OH region

Work Type

Hybrid work from home opportunities

Experience Level

10 years of clinical research experience
Experience in clinical project management
Experience in management of clinical trials

Education Level

Bachelor’s degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience

Benefits

Support career progression through a structured mentoring program
Leadership courses
Dedicated training department
Work-life balance support
CTI Cares program

About the Company

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.