Clinical Project Manager (level dependent on experience)

What You'll Do

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead
• Set goals, 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 a 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; able to effectively 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, timelines, schedules, resources, and budgets; work with team and assigned trial Director to provide effective solutions to challenges that arise during the clinical trial project
• 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 maintain 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 oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide 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 and collaborate with the assigned trial Director as needed to take corrective measures where necessary to keep project in line with budget
• Assess scope of work against client contractual agreement and inform assigned trial Director of any concerns; facilitate change of scope orders when appropriate
• Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensure 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 and/or approve meeting agendas or related materials and conducts 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'll 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
• At least 6 years clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry
• Graduate degree preferred
• At least 5 years of experience with therapeutic focus on rare disease, oncology, cell/gene therapy preferred
• Previous technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, a pharmaceutical company, or CRO preferred