CTI Clinical Trial and Consulting Services

Project Manager

• Plan, implement, facilitate and evaluate the full execution of assigned clinical trials; oversee management of multiple clinical trials from the planning phase to the analysis phase for delivery to client; may function as a global lead
• Ensure the operational aspects of the functional areas comply with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
• Ensure that assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) coordinate the organization and implementation of a clinical trial and manages the activities between all functional areas and the client
• Serve as primary senior interface on the project with executive management at CTI and the sponsor; provide effective client management to prevent and mitigate trial issues
• Oversee preparation of all study plans and project timelines and monitor against project progress; ensure project activity compliance with Plan(s)
• Assess resource needs with functional area managers and establish appropriate project team in conjunction with assigned CPM
• Ensure training of assigned project teams; participate in staff training for projects, dependent upon expertise

Associate Director, Clinical Project Management

Compliance

• Serve as a regulatory strategy lead and scientific advisor for sponsor programs across multiple therapeutic areas.
• Develop and advise on global regulatory strategies supporting clinical development programs from early phase through registration and post-approval.
• Provide strategic guidance on regulatory pathways, clinical development plans, and regulatory risk mitigation.
• Advise sponsors and internal teams on regulatory requirements, regulatory precedents, and optimal development approaches.
• Lead development of regulatory strategy for health authority interactions (FDA, EMA, MHRA, and other global agencies), including Pre-IND/Scientific Advice meetings; end of phase meetings; Type A, B, and C meetings; Pre-BLA/NDA/MAA meetings.
• Develop briefing packages, regulatory questions, and regulatory meeting strategy.
• Advise sponsors on regulatory positioning, regulatory risk, and agency expectations.
• Provide regulatory and scientific expertise to support successful regulatory outcomes.
• Provide regulatory and scientific expertise across CTI programs, including protocol design, endpoint selection, safety strategy, and development planning.
• Collaborate with Medical Affairs, MID, Clinical Operations, Pharmacovigilance, and Biostatistics to ensure regulatory and scientific alignment.
• Support regulatory and scientific strategy across complex and innovative programs, including rare disease, transplantation, advanced therapies, and biologics.
• Serve as a regulatory and scientific subject matter expert in sponsor interactions, proposals, and capabilities meetings.
• Support growth of CTI’s regulatory consulting and scientific affairs capabilities.
• Provide regulatory leadership and guidance to internal teams across CTI.
• Provide strategic input into protocol development and study design.
• Monitor evolving regulatory guidance, regulatory precedents, and scientific developments.
• Apply regulatory intelligence to support sponsor strategy and internal decision-making.
• Provide regulatory and scientific insights to CTI leadership and sponsors.
• Support internal KPI development related to strategic regulatory performance.
• Contribute to thought leadership activities and external scientific visibility.

Senior Director, Regulatory – Scientific Affairs

Research Analyst

• Serve as main CTI contact for assigned study sites
• Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
• Assist with study start-up activities, including feasibility, pre-study activities and site selection
• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study specific training as required
• Participate in investigator, client and project team meetings
• Create and implement subject enrollment strategies for assigned study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team
• May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
• Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
• Provide regular updates to Sponsor/ Client
• Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Identify site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary

Clinical Research Associate II

Vice President

• Drive execution of CTI’s commercial strategy by focusing on strengthening top-of-funnel activity
• Increase qualified RFP volume and ensure alignment with CCO’s vision and growth priorities
• Oversee Inside Sales, Proposal Writing, and content operations
• Partner closely with Marketing to ensure targeted campaigns are deployed through the right channels
• Develop and own a cohesive lead generation strategy focused on priority therapeutic areas
• Design and oversee repeatable, turnkey sales campaigns
• Establish a content operations model that engages SMEs to produce consistent, high-value content
• Support Proposal Writing group to ensure high-quality proposal content
• Define and continuously refine processes for prospecting, follow-up, and lead qualification
• Own and manage the commercial conference and event strategy

Associate Director, Clinical Project Management

Senior Director, Regulatory – Scientific Affairs

Clinical Research Associate II

Vice President, Commercial Enablement