CTI Clinical Trial and Consulting Services

Clinical Operations

• Plan, implement, evaluate, and complete full execution of assigned clinical trials
• Set goals, and timelines, provide oversight and leadership to accomplish goals
• Manage a full scope of clinical trial projects including global trials
• Coordinate operational aspects of assigned projects to ensure compliance with guidelines
• Assess project budget against milestones and collaborate on corrective measures

Clinical Project Manager – Senior

Medical Director

• Drive growth of a therapeutic area portfolio through medical and clinical development expertise and by providing medical oversight of awarded clinical trials
• Participate in the lifecycle of CTI’s work from early engagement to clinical consulting to RFP and bid defenses to clinical trial execution and delivery
• Accountable for medical oversight and management of awarded studies, including protocol review, eligibility discussions, oversight of medical issues, training of internal and site teams, safety review, and medical support of regulatory issues
• Early engagement business development activities, including providing advice and recommendations on protocols and clinical development plans, assessing key needs of sponsors, and applying innovations
• Responsible for working with a broad range of sponsors, creatively assessing opportunities, and developing strategies for trials and innovations for the execution of studies
• Use clinical, scientific, and operational knowledge to harness data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for clinical development projects, studies, and trials, addressing the specific needs and challenges of each customer
• Provide clinical and scientific expertise to all CTI departments as requested and collaborate closely with teams to develop integrated strategies for clinical trials and studies
• Partner with the regulatory team on clinical development plans, target product profiles, regulatory submissions, interactions with health authorities, and protocol development
• In partnership with Sales, Operations, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Along with other key experts, responsible for leading teams in developing focused proposals
• Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, understanding the standard of care and competitive landscape, informing strategies for site and country selection and patient recruitment
• Support preparation of customer and bid defense meetings, e.g., training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys therapeutic area strategy
• Attends and presents at customer meeting, or bid defense or partnership meetings, as required
• Responsible for staying current on industry pipeline and scientific and business landscape; does due diligence research of the therapeutic landscape; educates and informs CTI clinical and business teams about cutting-edge therapeutic developments
• Drive thought leadership activities including presentations, publications, and interactions with the medical scientific community to connect key areas of growth and innovation that CTI is focused on. which include cell and gene therapy and rare disease, and groundbreaking strategies to optimize the execution of clinical trials, using data and patient-centered approaches