CTI Clinical Trial and Consulting Services

Compliance

• Independently manage essential regulatory documentation for submission to various bodies for clinical studies
• Assist project teams on regulatory requirements
• Perform compliance assessments and notify Project Managers of findings
• Review and adapt study specific documents
• Oversee IRB/EC/CA submissions on behalf of sponsors
• Interact with site personnel for document corrections
• Compile regulatory documentation according to applicable country requirements
• Prepare for sponsor or agency audits and inspections

Senior Regulatory Affairs Study Start-Up Specialist

Vice President

• Provide executive medical oversight across global clinical trials (Phases I-IV)
• Oversee medical monitoring activities including development and review of Medical Monitoring Plans
• Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs), and other clinical parameters included in medical data review processes
• Partner with Pharmacovigilance, Regulatory, and Quality Assurance teams to ensure compliance with global regulations
• Serve as medical expert interacting with investigators, sponsors, and regulatory authorities
• Support study design, protocol development, and feasibility assessments
• Lead and contribute to RFP responses, including strategy, content, and medical positioning
• Participate in bid defense meetings, client presentations, and capabilities discussions
• Partner with Commercial/Sales teams to identify growth opportunities and expand client relationships
• Provide strategic medical input to win new business and increase revenue
• Represent the organization at industry events, conferences, and client meetings
• Provide medical leadership for consulting engagements and drug development programs
• Oversee development of clinical documents including protocols, CSRs, regulatory submissions, and publications
• Serve as subject matter expert for advisory boards and client engagements
• Ensure scientific integrity across all deliverables
• Develop and execute Medical Affairs strategy aligned with company growth objectives
• Oversee departmental budgeting, forecasting, and resource allocation
• Ensure development and maintenance of SOPs and implementation of best practices, creating an environment of continuous improvement
• Drive process improvements to enhance quality, efficiency, and client satisfaction
• Oversee administrative policies and processes associated with managing the Medical Affairs function, ensuring team members meet foundational expectations of their role
• Attract, develop and retain team members
• Coach and mentor Medical Directors, and Medical Affairs staff, and others as needed
• Drive performance management, succession planning, and team capability building
• Provide training and ongoing education for internal teams

Vice President, Global Medical Affairs

General

• Independently sources and analyzes data to develop site, country and investigator strategy or recommendations for proposals and post-award feasibility offerings
• Advise project teams on all Feasibility activities and/or strategy for clinical studies
• Research and apply critical thinking and analysis on the information available for therapeutic area(s)
• Conduct timely site follow-up on all aspects of the feasibility process
• Prepare presentations independently and/or written reports, as required

Senior Feasibility Specialist

Business Development Rep

• Achieve and/or exceed weekly and monthly sales metric targets set by CTI Sales Management
• Develop extensive knowledge about the benefits of CTI’s services and expertise
• Actively prospect and generate new sales and business opportunities within assigned customer territory and in support of the Business Development Director
• Support identification of cross-selling opportunities into other CTI business units, including RWE, RSA, and lab services
• Facilitate and attend introductory and capabilities meetings with new prospective clients for CTI
• Conduct ongoing research for the territory you support using available sales tools such as Salesforce, Zymewire, and other market research tools
• Qualify and respond to website leads
• Collaborate with the Business Development Director to support the sales process for new leads from initial introduction through bidding process and contract
• Gain commitment from Business Development Director to take part and lead introductory or capabilities call with new account(s); complete requests from prospective clients
• Develop and maintain excellent working relationships with key members of CTI’s clinical operational management and internal teams
• Develop and implement specific disease strategies to drive awareness, lead generation, and opportunity identification
• Support CTI Conference attendance and support the addition of additional client meeting efforts of the Business Development Sales Director as they attend therapeutically focused conferences globally
• Continuously monitor and update the status of leads in Salesforce to ensure the pipeline is maintained

Business Development Associate – Sales

Project Manager

• Plan, implement, evaluate, and complete execution of assigned laboratory clinical trials/projects; may function as a global lead, where applicable.
• Expected to manage medium to high complexity trials.
• 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 laboratory clinical trials/projects
• Provide oversight and coordination of the operational aspects of the functional areas on assigned clinical trials/projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, and laboratory procedures
• Provide management of the full scope of laboratory clinical trials/projects including global clinical trials/projects from start-up through closeout; provide oversight of functionally assigned teams members on laboratory clinical trials/projects; manage multiple clinical trials/projects simultaneously
• Work closely with the CTI Clinical Project Manager and Team members on full service clinical trials/projects
• Provide coordination of a laboratory clinical trial/project including organization, implementation, and management of scoped activities
• Prepare or provide oversight to the development of project plans and timelines; work with laboratory leadership and/or line manager to provide effective solutions to challenges that arise during the laboratory clinical trial/project
• Participate in or provide oversight and guidance in the development of clinical trial/project required deliverables
• Serve as Global Project Manager and/or client contact at clinical trial/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 clinical trial/project tracking using computer-assisted programs and ensure timely entry of project information by all project team members to enable accurate reporting to clients and CTI executive management
• Monitor ongoing resource needs to the clinical trial/project; keep appropriate functional department heads apprised of any identified resource needs or performance issues
• Ensure that assigned clinical trial/project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the clinical trial/project
• In conjunction with the client and cross-functional CTI laboratory departments, create the Laboratory Specifications Plan based upon contracted services at the initiation of a new clinical trial/project, and maintain and update the document as needed throughout the lifecycle of the clinical trial/project
• Build clinical trial/project-specific laboratory database in lab information management system (LIMS) at initiation of a new clinical trial/project; maintain and update the database as needed throughout the lifecycle of the clinical trial/project.
• Develop project-specific site tools such as the Laboratory Manual and Quick Reference Guides (if applicable); maintain and update these documents as applicable throughout the lifecycle of the clinical trial/project
• Work with cross-functional CTI laboratory departments to design clinical trial/project-specific tools and supplies such as sample requisition forms, sample labels, and lab kits
• Serve as liaison between logistics and data management to resolve issues with samples
• Implement project activities according to scope of contracted work
• Coordinate shipment of stored samples as directed by the scope of work and supporting documents, in conjunction with the client
• Evaluate and manage clinical trial/project budget against project milestones and scope; work with laboratory leadership to take corrective measures where necessary to keep clinical trial/project in line with budget
• Assess scope of work against client contractual agreements and works with laboratory leadership 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 clinical trial/project status reports for assigned projects
• Participate and contribute to site training meetings, such as Investigator meetings or site initiation visits
• Suggest and participate in process improvement activities and initiatives.

Project Manager, Laboratory Services

Research Analyst

• Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies
• Serve as the 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 the 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 the Clinical Project Manager
• Conduct remote monitoring and complete 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 a member of the Project Team
• May support in the 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 the 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 on the evaluation process until approval is available.
• Provide regular updates to the Sponsor/ Client
• Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary
• Liaise with Clinical Data Management for data cleaning activities
• Identify site issues and implement corrective actions or escalate as appropriate
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Where applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site payments

Senior Clinical Research Associate

• 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;
• 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; escalate identified trial, CPM 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 Plan(s); suggest and implement alternative solutions to problems with study timelines, schedules, resources, budgets, etc.
• Take corrective action where necessary
• Assess resource needs within team, with other CPM directors, Executive Director and other functional area managers to establish appropriate project team; monitor ongoing resource needs for project
• Ensure that appropriate project management tools are used to track and report project progress and metrics; ensure timely entry of project information by all team members throughout the life of the project
• Ensure training of assigned project teams; participate in staff training for his/her projects or other projects, dependent upon expertise
• Oversee the management of budgeted hours by the CPM, who evaluates and manages regional project budget against project milestones; ensure that the CPM takes corrective measures where necessary to keep project in line with budget expectations
• Ensure that the 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 the sponsor expectations to develop strategies to facilitate effective problem solving and advancement of the project; keep CTI executive management and the client informed; ensure that the CPM initiates corrective action
• Conduct or attend trial team and sponsor meetings; ensure that 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 as needed prior to forwarding to client to ensure the quality of those reports, 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 the CPM’s skills; provide regular performance evaluation and feedback to direct reports
• 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; participate in the development and enhancement of integral aspects of the CPM operations
• 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
• Coach and train others in the CPM practices; promote and actively participate in the professional development of all CPM and CPC staff
• Participate in business development opportunities and the enhancement of globalization processes