Clinical Project Manager II

About CTI

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. For more information, visit www.ctifacts.com

What You’ll Do

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; may function as a global trial lead 
• Set goals and timelines, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials 
• Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures 
• Provide management of full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; manage multiple projects simultaneously 
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities 
• Prepare or provide oversight to the development of trial plans and timelines; work with the trial-assigned Director or line manager to provide effective solutions to challenges that arise during the clinical trial project 
• Participate in or provide oversight and guidance in the development of trial required deliverables 
• Serve as client contact at project operational level 
• Provide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations 
• Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management 
• Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues 
• Ensure that assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol   
• Provide day-to-day oversight of Clinical Research Associate (CRA) tasks on assigned projects; provides oversight of the CRA’s management of sites and monitoring of the clinical trial data Review and approve site trip reports and escalates site issues as needed to assigned trial Director, CTI executive management and/or client/sponsor in accordance with the trial’s Communication Plan    
• Attend site visits on an as-needed basis to provide support to CTI and/or site staff 
• Implement project activities according to scope of contracted work 
• Evaluate and manage project budget against project milestones and scope; work with the trial-assigned Director to take corrective measures where necessary to keep project in line with budget 
• Assess scope of work against client contractual agreements and works with trial-assigned Director to facilitate change of scope orders when appropriate 
• Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomes 
• Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects 
• Participate and provide oversight in the planning of Investigator meetings; develop meeting agendas or related materials and conduct presentations 
• Provide oversight in the management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial’s TMF Plan   
• Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.) 
• Suggest and participate in process improvement activities and initiatives  

What You Bring

• 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 
• 4 to 6 years clinical research experience (CRO CRA or Clinical Research Manager, Site Coordinator or Research Manager, Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry

Why CTI?

• We support career progression - We have a structured mentoring program to provide the support you need to move forward
• We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• We think globally and act locally - We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
• We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
• Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Are you interested? Then, we look forward to your electronic application.

CTI Clinical Trial and Consulting Services